Bipolar combination device that automatically adjusts pressure based on energy modality

ABSTRACT

A surgical instrument, system and method for adjusting a compression force applied by a surgical instrument are disclosed. The method includes determining tissue impedance of tissue in contact with an end effector of the surgical instrument, determining a tissue type based on the tissue impedance, selecting a first energy modality to deliver to the surgical instrument, generating a first signal waveform based on the first energy modality, selecting a second energy modality to deliver to the surgical instrument, generating a second signal waveform based on the second energy modality, outputting the first and second signal waveform to deliver energy to the end effector, and adjusting a compression force applied by the end effector by changing a size of a gap between the tissue and the clamp arm based on a proportion of the first signal waveform to the second signal waveform.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application claims priority under 35 U.S.C. § 119(e) to U.S.Provisional Patent Application No. 62/721,995, titled CONTROLLING ANULTRASONIC SURGICAL INSTRUMENT ACCORDING TO TISSUE LOCATION, filed onAug. 23, 2018, the disclosure of which is herein incorporated byreference in its entirety.

The present application claims priority under 35 U.S.C. § 119(e) to U.S.Provisional Patent Application No. 62/721,998, titled SITUATIONALAWARENESS OF ELECTROSURGICAL SYSTEMS, filed on Aug. 23, 2018, thedisclosure of which is herein incorporated by reference in its entirety.

The present application claims priority under 35 U.S.C. § 119(e) to U.S.Provisional Patent Application No. 62/721,999, titled INTERRUPTION OFENERGY DUE TO INADVERTENT CAPACITIVE COUPLING, filed on Aug. 23, 2018,the disclosure of which is herein incorporated by reference in itsentirety.

The present application claims priority under 35 U.S.C. § 119(e) to U.S.Provisional Patent Application No. 62/721,994, titled BIPOLARCOMBINATION DEVICE THAT AUTOMATICALLY ADJUSTS PRESSURE BASED ON ENERGYMODALITY, filed on Aug. 23, 2018, the disclosure of which is hereinincorporated by reference in its entirety.

The present application claims priority under 35 U.S.C. § 119(e) to U.S.Provisional Patent Application No. 62/721,996, titled RADIO FREQUENCYENERGY DEVICE FOR DELIVERING COMBINED ELECTRICAL SIGNALS, filed on Aug.23, 2018, the disclosure of which is herein incorporated by reference inits entirety.

The present application also claims priority under 35 U.S.C. § 119(e) toU.S. Provisional Patent Application No. 62/692,747, titled SMARTACTIVATION OF AN ENERGY DEVICE BY ANOTHER DEVICE, filed on Jun. 30,2018, to U.S. Provisional Patent Application No. 62/692,748, titledSMART ENERGY ARCHITECTURE, filed on Jun. 30, 2018, and to U.S.Provisional Patent Application No. 62/692,768, titled SMART ENERGYDEVICES, filed on Jun. 30, 2018, the disclosure of each of which isherein incorporated by reference in its entirety.

This application also claims the benefit of priority under 35 U.S.C. §119(e) to U.S. Provisional Patent Application No. 62/650,898 filed onMar. 30, 2018, titled CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLEARRAY ELEMENTS, to U.S. Provisional Patent Application Ser. No.62/650,887, titled SURGICAL SYSTEMS WITH OPTIMIZED SENSING CAPABILITIES,filed Mar. 30, 2018, to U.S. Provisional Patent Application Ser. No.62/650,882, titled SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICALPLATFORM, filed Mar. 30, 2018, and to U.S. Provisional PatentApplication Ser. No. 62/650,877, titled SURGICAL SMOKE EVACUATIONSENSING AND CONTROLS, filed Mar. 30, 2018, the disclosure of each ofwhich is herein incorporated by reference in its entirety.

This application also claims the benefit of priority under 35 U.S.C. §119(e) to U.S. Provisional Patent Application Ser. No. 62/611,341,titled INTERACTIVE SURGICAL PLATFORM, filed Dec. 28, 2017, to U.S.Provisional Patent Application Ser. No. 62/611,340, titled CLOUD-BASEDMEDICAL ANALYTICS, filed Dec. 28, 2017, and to U.S. Provisional PatentApplication Ser. No. 62/611,339, titled ROBOT ASSISTED SURGICALPLATFORM, filed Dec. 28, 2017, the disclosure of each of which is hereinincorporated by reference in its entirety.

BACKGROUND

In a surgical environment, smart energy devices may be needed in a smartenergy architecture environment.

SUMMARY

In one general aspect, a method of adjusting a compression force appliedby a surgical instrument is provided. The surgical instrument comprisesan end effector and a clamp arm configured to receive energy modalitiesfrom a generator configured to deliver a plurality of energy modalitiesto the surgical instrument. The method comprising: determining, by acontrol circuit, tissue impedance of tissue in contact with an endeffector of the surgical instrument; determining, by the controlcircuit, a tissue type based on the tissue impedance; selecting, by thecontrol circuit, a first energy modality of the plurality of energymodalities to deliver to the surgical instrument; generating, by thecontrol circuit, a first signal waveform based on the first energymodality; selecting, by the control circuit, a second energy modality ofthe plurality of energy modalities to deliver to the surgicalinstrument; generating, by the control circuit, a second signal waveformbased on the second energy modality; outputting, by the generator, thefirst and second signal waveform to deliver energy to the end effector;and adjusting, by the control circuit, a compression force applied bythe end effector by changing a size of a gap between the tissue and theclamp arm based on a proportion of the first signal waveform to thesecond signal waveform.

In another aspect, a surgical instrument is provided. The surgicalinstrument comprising: a control circuit configured to communicativelycouple to a generator configured to deliver a plurality of energymodalities to an end effector of the surgical instrument, wherein thecontrol circuit is further configured to: determine tissue impedance oftissue in contact with an end effector of the surgical instrument;determine a tissue type of based on the tissue impedance; select a firstenergy modality of the plurality of energy modalities; generate a firstsignal waveform based on the first energy modality; select a secondenergy modality of the plurality of energy modalities; generate a secondsignal waveform based on the second energy modality; and adjust acompression force applied by an end effector to tissue by changing a gapbetween tissue and an end effector based on a proportion of the firstsignal waveform to the second signal waveform.

In yet another aspect, a surgical system is provided. The surgicalsystem comprising: a surgical hub configured to receive a tissuetreatment algorithm transmitted from a cloud computing system, whereinthe surgical hub is communicatively coupled to the cloud computingsystem; and a surgical instrument communicatively coupled to thesurgical hub, wherein the surgical instrument comprises: an end effectorcomprising: a clamp arm; and a ultrasonic blade; a generator configuredto deliver a plurality of energy modalities to the end effector; acontrol circuit communicatively coupled to the end effector and thegenerator, wherein the control circuit is configured to treat tissue,and wherein the control circuit is configured to: determine tissueimpedance of tissue in contact with the end effector; determine tissuetype based on the tissue impedance; select a first energy modality ofthe plurality of energy modalities; generating a first signal waveformbased on the first energy modality; selecting a second energy modalityof the plurality of energy modalities; generating a second signalwaveform based on the second energy modality; applying the first andsecond signal waveform to the end effector; and adjusting a compressionforce applied by the end effector by changing a size of a gap betweenthe tissue and the waveguide based on a proportion of the first signalwaveform to the second signal waveform.

FIGURES

The features of various aspects are set forth with particularity in theappended claims. The various aspects, however, both as to organizationand methods of operation, together with further objects and advantagesthereof, may best be understood by reference to the followingdescription, taken in conjunction with the accompanying drawings asfollows.

FIG. 1 is a block diagram of a computer-implemented interactive surgicalsystem, in accordance with at least one aspect of the presentdisclosure.

FIG. 2 is a surgical system being used to perform a surgical procedurein an operating room, in accordance with at least one aspect of thepresent disclosure.

FIG. 3 is a surgical hub paired with a visualization system, a roboticsystem, and an intelligent instrument, in accordance with at least oneaspect of the present disclosure.

FIG. 4 is a partial perspective view of a surgical hub enclosure, and ofa combo generator module slidably receivable in a drawer of the surgicalhub enclosure, in accordance with at least one aspect of the presentdisclosure.

FIG. 5 is a perspective view of a combo generator module with bipolar,ultrasonic, and monopolar contacts and a smoke evacuation component, inaccordance with at least one aspect of the present disclosure.

FIG. 6 illustrates a surgical data network comprising a modularcommunication hub configured to connect modular devices located in oneor more operating theaters of a healthcare facility, or any room in ahealthcare facility specially equipped for surgical operations, to thecloud, in accordance with at least one aspect of the present disclosure.

FIG. 7 illustrates a computer-implemented interactive surgical system,in accordance with at least one aspect of the present disclosure.

FIG. 8 illustrates a surgical hub comprising a plurality of modulescoupled to the modular control tower, in accordance with at least oneaspect of the present disclosure.

FIG. 9 illustrates one aspect of a Universal Serial Bus (USB) networkhub device, in accordance with at least one aspect of the presentdisclosure.

FIG. 10 illustrates a logic diagram of a control system of a surgicalinstrument or tool, in accordance with at least one aspect of thepresent disclosure.

FIG. 11 illustrates a control circuit configured to control aspects ofthe surgical instrument or tool, in accordance with at least one aspectof the present disclosure.

FIG. 12 illustrates a combinational logic circuit configured to controlaspects of the surgical instrument or tool, in accordance with at leastone aspect of the present disclosure.

FIG. 13 illustrates a sequential logic circuit configured to controlaspects of the surgical instrument or tool, in accordance with at leastone aspect of the present disclosure.

FIG. 14 illustrates a surgical instrument or tool comprising a pluralityof motors which can be activated to perform various functions, inaccordance with at least one aspect of the present disclosure.

FIG. 15 is a schematic diagram of a robotic surgical instrumentconfigured to operate a surgical tool described herein, in accordancewith at least one aspect of the present disclosure.

FIG. 16 illustrates a block diagram of a surgical instrument programmedto control the distal translation of a displacement member, inaccordance with at least one aspect of the present disclosure.

FIG. 17 is a schematic diagram of a surgical instrument configured tocontrol various functions, in accordance with at least one aspect of thepresent disclosure.

FIG. 18 is a system configured to execute adaptive ultrasonic bladecontrol algorithms in a surgical data network comprising a modularcommunication hub, in accordance with at least one aspect of the presentdisclosure.

FIG. 19 illustrates an example of a generator, in accordance with atleast one aspect of the present disclosure.

FIG. 20 is a surgical system comprising a generator and various surgicalinstruments usable therewith, in accordance with at least one aspect ofthe present disclosure.

FIG. 21 is an end effector, in accordance with at least one aspect ofthe present disclosure.

FIG. 22 is a model illustrating motional branch current, in accordancewith at least one aspect of the present disclosure.

FIG. 23 is a structural view of a generator architecture, in accordancewith at least one aspect of the present disclosure.

FIGS. 24A-24C are functional views of a generator architecture, inaccordance with at least one aspect of the present disclosure.

FIGS. 25A-25B are structural and functional aspects of a generator, inaccordance with at least one aspect of the present disclosure.

FIG. 26 is a schematic diagram of one aspect of an ultrasonic drivecircuit.

FIG. 27 is a schematic diagram of a control circuit, in accordance withat least one aspect of the present disclosure.

FIG. 28 shows a simplified block circuit diagram illustrating anotherelectrical circuit contained within a modular ultrasonic surgicalinstrument, in accordance with at least one aspect of the presentdisclosure.

FIG. 29 illustrates a generator circuit partitioned into multiplestages, in accordance with at least one aspect of the presentdisclosure.

FIG. 30 illustrates a generator circuit partitioned into multiple stageswhere a first stage circuit is common to the second stage circuit, inaccordance with at least one aspect of the present disclosure.

FIG. 31 is a schematic diagram of one aspect of a drive circuitconfigured for driving a high-frequency current (RF), in accordance withat least one aspect of the present disclosure.

FIG. 32 illustrates a control circuit that allows a dual generatorsystem to switch between the RF generator and the ultrasonic generatorenergy modalities for a surgical instrument.

FIG. 33 illustrates a diagram of one aspect of a surgical instrumentcomprising a feedback system for use with a surgical instrument,according to one aspect of the resent disclosure.

FIG. 34 illustrates one aspect of a fundamental architecture for adigital synthesis circuit such as a direct digital synthesis (DDS)circuit configured to generate a plurality of wave shapes for theelectrical signal waveform for use in a surgical instrument, inaccordance with at least one aspect of the present disclosure.

FIG. 35 illustrates one aspect of direct digital synthesis (DDS) circuitconfigured to generate a plurality of wave shapes for the electricalsignal waveform for use in surgical instrument, in accordance with atleast one aspect of the present disclosure.

FIG. 36 illustrates one cycle of a discrete time digital electricalsignal waveform, in accordance with at least one aspect of the presentdisclosure of an analog waveform (shown superimposed over a discretetime digital electrical signal waveform for comparison purposes), inaccordance with at least one aspect of the present disclosure.

FIG. 37 is a diagram of a control system configured to provideprogressive closure of a closure member as it advances distally to closethe clamp arm to apply a closure force load at a desired rate accordingto one aspect of this disclosure.

FIG. 38 illustrates a proportional-integral-derivative (PID) controllerfeedback control system according to one aspect of this disclosure.

FIG. 39 is an elevational exploded view of modular handheld ultrasonicsurgical instrument showing the left shell half removed from a handleassembly exposing a device identifier communicatively coupled to themulti-lead handle terminal assembly in accordance with one aspect of thepresent disclosure.

FIG. 40 is a detail view of a trigger portion and switch of theultrasonic surgical instrument shown in FIG. 39, in accordance with atleast one aspect of the present disclosure.

FIG. 41 is a fragmentary, enlarged perspective view of an end effectorfrom a distal end with a jaw member in an open position, in accordancewith at least one aspect of the present disclosure.

FIG. 42 illustrates one aspect of an end effector comprising RF datasensors located on the jaw member, in accordance with at least oneaspect of the present disclosure.

FIG. 43 is a spectra of the same ultrasonic device with a variety ofdifferent states and conditions of the end effector where phase andmagnitude of the impedance of an ultrasonic transducer are plotted as afunction of frequency, in accordance with at least one aspect of thepresent disclosure.

FIG. 44 is a graphical representation of a plot of a set of 3D trainingdata S, where ultrasonic transducer impedance magnitude and phase areplotted as a function of frequency, in accordance with at least oneaspect of the present disclosure.

FIG. 45 is a logic flow diagram depicting a control program or a logicconfiguration to adjust compression force applied to tissue, based onone or more selected energy modalities, according to a least one aspectof the present disclosure.

FIG. 46 illustrates a mechanical method of adjusting compression forceapplied by an end effector for different treatment types, in accordancewith at least one aspect of the present disclosure.

FIGS. 47A-47B illustrate a mechanical method of adjusting compressionforce applied by an end effector for different treatment types, byrotating an ultrasonic blade, in accordance with at least one aspect ofthe present disclosure.

FIG. 48 shows a diagram illustrating switching between active electrodesof an end effector, in accordance with at least one aspect of thepresent disclosure.

FIG. 49 is a timeline depicting situational awareness of a surgical hub,in accordance with at least one aspect of the present disclosure.

DESCRIPTION

Applicant of the present application owns the following U.S. patentapplications, filed on Aug. 28, 2018, the disclosure of each of which isherein incorporated by reference in its entirety:

-   -   U.S. patent application Ser. No. 16/115,214, titled ESTIMATING        STATE OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR,        now U.S. Patent Application Publication No. 2019/0201073;    -   U.S. patent application Ser. No. 16/115,205, titled TEMPERATURE        CONTROL OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR,        now U.S. Patent Application Publication No. 2019/0201036;    -   U.S. patent application Ser. No. 16/115,233, titled RADIO        FREQUENCY ENERGY DEVICE FOR DELIVERING COMBINED ELECTRICAL        SIGNALS, now U.S. Patent Application Publication No.        2019/0201091;    -   U.S. patent application Ser. No. 16/115,208, titled CONTROLLING        AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO TISSUE LOCATION,        now U.S. Patent Application Publication No. 2019/0201037;    -   U.S. patent application Ser. No. 16/115,220, titled CONTROLLING        ACTIVATION OF AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO THE        PRESENCE OF TISSUE, now U.S. Patent Application Publication No.        2019/0201040;    -   U.S. patent application Ser. No. 16/115,232, titled DETERMINING        TISSUE COMPOSITION VIA AN ULTRASONIC SYSTEM, now U.S. Patent        Application Publication No. 2019/0201038;    -   U.S. patent application Ser. No. 16/115,239, titled DETERMINING        THE STATE OF AN ULTRASONIC ELECTROMECHANICAL SYSTEM ACCORDING TO        FREQUENCY SHIFT, now U.S. Patent Application Publication No.        2019/0201042;    -   U.S. patent application Ser. No. 16/115,247, titled DETERMINING        THE STATE OF AN ULTRASONIC END EFFECTOR, now U.S. Patent        Application Publication No. 2019/0274716;    -   U.S. patent application Ser. No. 16/115,211, titled SITUATIONAL        AWARENESS OF ELECTROSURGICAL SYSTEMS, now U.S. Patent        Application Publication No. 2019/0201039;    -   U.S. patent application Ser. No. 16/115,226, titled MECHANISMS        FOR CONTROLLING DIFFERENT ELECTROMECHANICAL SYSTEMS OF AN        ELECTROSURGICAL INSTRUMENT, now U.S. Patent Application        Publication No. 2019/0201075;    -   U.S. patent application Ser. No. 16/115,240, titled DETECTION OF        END EFFECTOR IMMERSION IN LIQUID, now U.S. Patent Application        Publication No. 2019/0201043;    -   U.S. patent application Ser. No. 16/115,249, titled INTERRUPTION        OF ENERGY DUE TO INADVERTENT CAPACITIVE COUPLING, now U.S.        Patent Application Publication No. 2019/0201077;    -   U.S. patent application Ser. No. 16/115,256, titled INCREASING        RADIO FREQUENCY TO CREATE PAD-LESS MONOPOLAR LOOP, now U.S.        Patent Application Publication No. 2019/0201092; and    -   U.S. patent application Ser. No. 16/115,238, titled ACTIVATION        OF ENERGY DEVICES, now U.S. Patent Application Publication No.        2019/0201041.

Applicant of the present application owns the following U.S. patentapplications, filed on Aug. 23, 2018, the disclosure of each of which isherein incorporated by reference in its entirety:

-   -   U.S. Provisional Patent Application No. 62/721,995, titled        CONTROLLING AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO        TISSUE LOCATION;    -   U.S. Provisional Patent Application No. 62/721,998, titled        SITUATIONAL AWARENESS OF ELECTROSURGICAL SYSTEMS;    -   U.S. Provisional Patent Application No. 62/721,999, titled        INTERRUPTION OF ENERGY DUE TO INADVERTENT CAPACITIVE COUPLING;    -   U.S. Provisional Patent Application No. 62/721,994, titled        BIPOLAR COMBINATION DEVICE THAT AUTOMATICALLY ADJUSTS PRESSURE        BASED ON ENERGY MODALITY; and    -   U.S. Provisional Patent Application No. 62/721,996, titled RADIO        FREQUENCY ENERGY DEVICE FOR DELIVERING COMBINED ELECTRICAL        SIGNALS.

Applicant of the present application owns the following U.S. patentapplications, filed on Jun. 30, 2018, the disclosure of each of which isherein incorporated by reference in its entirety:

-   -   U.S. Provisional Patent Application No. 62/692,747, titled SMART        ACTIVATION OF AN ENERGY DEVICE BY ANOTHER DEVICE;    -   U.S. Provisional Patent Application No. 62/692,748, titled SMART        ENERGY ARCHITECTURE; and    -   U.S. Provisional Patent Application No. 62/692,768, titled SMART        ENERGY DEVICES.

Applicant of the present application owns the following U.S. patentapplications, filed on Jun. 29, 2018, the disclosure of each of which isherein incorporated by reference in its entirety:

-   -   U.S. patent application Ser. No. 16/024,090, titled CAPACITIVE        COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS;    -   U.S. patent application Ser. No. 16/024,057, titled CONTROLLING        A SURGICAL INSTRUMENT ACCORDING TO SENSED CLOSURE PARAMETERS;    -   U.S. patent application Ser. No. 16/024,067, titled SYSTEMS FOR        ADJUSTING END EFFECTOR PARAMETERS BASED ON PERIOPERATIVE        INFORMATION;    -   U.S. patent application Ser. No. 16/024,075, titled SAFETY        SYSTEMS FOR SMART POWERED SURGICAL STAPLING;    -   U.S. patent application Ser. No. 16/024,083, titled SAFETY        SYSTEMS FOR SMART POWERED SURGICAL STAPLING;    -   U.S. patent application Ser. No. 16/024,094, titled SURGICAL        SYSTEMS FOR DETECTING END EFFECTOR TISSUE DISTRIBUTION        IRREGULARITIES;    -   U.S. patent application Ser. No. 16/024,138, titled SYSTEMS FOR        DETECTING PROXIMITY OF SURGICAL END EFFECTOR TO CANCEROUS        TISSUE;    -   U.S. patent application Ser. No. 16/024,150, titled SURGICAL        INSTRUMENT CARTRIDGE SENSOR ASSEMBLIES;    -   U.S. patent application Ser. No. 16/024,160, titled VARIABLE        OUTPUT CARTRIDGE SENSOR ASSEMBLY;    -   U.S. patent application Ser. No. 16/024,124, titled SURGICAL        INSTRUMENT HAVING A FLEXIBLE ELECTRODE;    -   U.S. patent application Ser. No. 16/024,132, titled SURGICAL        INSTRUMENT HAVING A FLEXIBLE CIRCUIT;    -   U.S. patent application Ser. No. 16/024,141, titled SURGICAL        INSTRUMENT WITH A TISSUE MARKING ASSEMBLY;    -   U.S. patent application Ser. No. 16/024,162, titled SURGICAL        SYSTEMS WITH PRIORITIZED DATA TRANSMISSION CAPABILITIES;    -   U.S. patent application Ser. No. 16/024,066, titled SURGICAL        EVACUATION SENSING AND MOTOR CONTROL;    -   U.S. patent application Ser. No. 16/024,096, titled SURGICAL        EVACUATION SENSOR ARRANGEMENTS;    -   U.S. patent application Ser. No. 16/024,116, titled SURGICAL        EVACUATION FLOW PATHS;    -   U.S. patent application Ser. No. 16/024,149, titled SURGICAL        EVACUATION SENSING AND GENERATOR CONTROL;    -   U.S. patent application Ser. No. 16/024,180, titled SURGICAL        EVACUATION SENSING AND DISPLAY;    -   U.S. patent application Ser. No. 16/024,245, titled        COMMUNICATION OF SMOKE EVACUATION SYSTEM PARAMETERS TO HUB OR        CLOUD IN SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL        PLATFORM;    -   U.S. patent application Ser. No. 16/024,258, titled SMOKE        EVACUATION SYSTEM INCLUDING A SEGMENTED CONTROL CIRCUIT FOR        INTERACTIVE SURGICAL PLATFORM;    -   U.S. patent application Ser. No. 16/024,265, titled SURGICAL        EVACUATION SYSTEM WITH A COMMUNICATION CIRCUIT FOR COMMUNICATION        BETWEEN A FILTER AND A SMOKE EVACUATION DEVICE; and    -   U.S. patent application Ser. No. 16/024,273, titled DUAL        IN-SERIES LARGE AND SMALL DROPLET FILTERS.

Applicant of the present application owns the following U.S. ProvisionalPatent Applications, filed on Jun. 28, 2018, the disclosure of each ofwhich is herein incorporated by reference in its entirety:

-   -   U.S. Provisional Patent Application Ser. No. 62/691,228, titled        A METHOD OF USING REINFORCED FLEX CIRCUITS WITH MULTIPLE SENSORS        WITH ELECTROSURGICAL DEVICES;    -   U.S. Provisional Patent Application Ser. No. 62/691,227, titled        CONTROLLING A SURGICAL INSTRUMENT ACCORDING TO SENSED CLOSURE        PARAMETERS;    -   U.S. Provisional Patent Application Ser. No. 62/691,230, titled        SURGICAL INSTRUMENT HAVING A FLEXIBLE ELECTRODE;    -   U.S. Provisional Patent Application Ser. No. 62/691,219, titled        SURGICAL EVACUATION SENSING AND MOTOR CONTROL;    -   U.S. Provisional Patent Application Ser. No. 62/691,257, titled        COMMUNICATION OF SMOKE EVACUATION SYSTEM PARAMETERS TO HUB OR        CLOUD IN SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL        PLATFORM;    -   U.S. Provisional Patent Application Ser. No. 62/691,262, titled        SURGICAL EVACUATION SYSTEM WITH A COMMUNICATION CIRCUIT FOR        COMMUNICATION BETWEEN A FILTER AND A SMOKE EVACUATION DEVICE;        and    -   U.S. Provisional Patent Application Ser. No. 62/691,251, titled        DUAL IN-SERIES LARGE AND SMALL DROPLET FILTERS.

Applicant of the present application owns the following U.S. ProvisionalPatent Application, filed on Apr. 19, 2018, the disclosure of each ofwhich is herein incorporated by reference in its entirety:

-   -   U.S. Provisional Patent Application Ser. No. 62/659,900, titled        METHOD OF HUB COMMUNICATION.

Applicant of the present application owns the following U.S. ProvisionalPatent Applications, filed on Mar. 30, 2018, the disclosure of each ofwhich is herein incorporated by reference in its entirety:

-   -   U.S. Provisional Patent Application No. 62/650,898 filed on Mar.        30, 2018, titled CAPACITIVE COUPLED RETURN PATH PAD WITH        SEPARABLE ARRAY ELEMENTS;    -   U.S. Provisional Patent Application Ser. No. 62/650,887, titled        SURGICAL SYSTEMS WITH OPTIMIZED SENSING CAPABILITIES;    -   U.S. Provisional Patent Application Ser. No. 62/650,882, titled        SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM; and    -   U.S. Provisional Patent Application Ser. No. 62/650,877, titled        SURGICAL SMOKE EVACUATION SENSING AND CONTROLS.

Applicant of the present application owns the following U.S. patentapplications, filed on Mar. 29, 2018, the disclosure of each of which isherein incorporated by reference in its entirety:

-   -   U.S. patent application Ser. No. 15/940,641, titled INTERACTIVE        SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES;    -   U.S. patent application Ser. No. 15/940,648, titled INTERACTIVE        SURGICAL SYSTEMS WITH CONDITION HANDLING OF DEVICES AND DATA        CAPABILITIES;    -   U.S. patent application Ser. No. 15/940,656, titled SURGICAL HUB        COORDINATION OF CONTROL AND COMMUNICATION OF OPERATING ROOM        DEVICES;    -   U.S. patent application Ser. No. 15/940,666, titled SPATIAL        AWARENESS OF SURGICAL HUBS IN OPERATING ROOMS;    -   U.S. patent application Ser. No. 15/940,670, titled COOPERATIVE        UTILIZATION OF DATA DERIVED FROM SECONDARY SOURCES BY        INTELLIGENT SURGICAL HUBS;    -   U.S. patent application Ser. No. 15/940,677, titled SURGICAL HUB        CONTROL ARRANGEMENTS;    -   U.S. patent application Ser. No. 15/940,632, titled DATA        STRIPPING METHOD TO INTERROGATE PATIENT RECORDS AND CREATE        ANONYMIZED RECORD;    -   U.S. patent application Ser. No. 15/940,640, titled        COMMUNICATION HUB AND STORAGE DEVICE FOR STORING PARAMETERS AND        STATUS OF A SURGICAL DEVICE TO BE SHARED WITH CLOUD BASED        ANALYTICS SYSTEMS;    -   U.S. patent application Ser. No. 15/940,645, titled SELF        DESCRIBING DATA PACKETS GENERATED AT AN ISSUING INSTRUMENT;    -   U.S. patent application Ser. No. 15/940,649, titled DATA PAIRING        TO INTERCONNECT A DEVICE MEASURED PARAMETER WITH AN OUTCOME;    -   U.S. patent application Ser. No. 15/940,654, titled SURGICAL HUB        SITUATIONAL AWARENESS;    -   U.S. patent application Ser. No. 15/940,663, titled SURGICAL        SYSTEM DISTRIBUTED PROCESSING;    -   U.S. patent application Ser. No. 15/940,668, titled AGGREGATION        AND REPORTING OF SURGICAL HUB DATA;    -   U.S. patent application Ser. No. 15/940,671, titled SURGICAL HUB        SPATIAL AWARENESS TO DETERMINE DEVICES IN OPERATING THEATER;    -   U.S. patent application Ser. No. 15/940,686, titled DISPLAY OF        ALIGNMENT OF STAPLE CARTRIDGE TO PRIOR LINEAR STAPLE LINE;    -   U.S. patent application Ser. No. 15/940,700, titled STERILE        FIELD INTERACTIVE CONTROL DISPLAYS;    -   U.S. patent application Ser. No. 15/940,629, titled COMPUTER        IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS;    -   U.S. patent application Ser. No. 15/940,704, titled USE OF LASER        LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE PROPERTIES OF        BACK SCATTERED LIGHT;    -   U.S. patent application Ser. No. 15/940,722, titled        CHARACTERIZATION OF TISSUE IRREGULARITIES THROUGH THE USE OF        MONO-CHROMATIC LIGHT REFRACTIVITY; and    -   U.S. patent application Ser. No. 15/940,742, titled DUAL CMOS        ARRAY IMAGING.    -   U.S. patent application Ser. No. 15/940,636, titled ADAPTIVE        CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES;    -   U.S. patent application Ser. No. 15/940,653, titled ADAPTIVE        CONTROL PROGRAM UPDATES FOR SURGICAL HUBS;    -   U.S. patent application Ser. No. 15/940,660, titled CLOUD-BASED        MEDICAL ANALYTICS FOR CUSTOMIZATION AND RECOMMENDATIONS TO A        USER;    -   U.S. patent application Ser. No. 15/940,679, titled CLOUD-BASED        MEDICAL ANALYTICS FOR LINKING OF LOCAL USAGE TRENDS WITH THE        RESOURCE ACQUISITION BEHAVIORS OF LARGER DATA SET;    -   U.S. patent application Ser. No. 15/940,694, titled CLOUD-BASED        MEDICAL ANALYTICS FOR MEDICAL FACILITY SEGMENTED        INDIVIDUALIZATION OF INSTRUMENT FUNCTION;    -   U.S. patent application Ser. No. 15/940,634, titled CLOUD-BASED        MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION TRENDS AND        REACTIVE MEASURES;    -   U.S. patent application Ser. No. 15/940,706, titled DATA        HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICS NETWORK; and    -   U.S. patent application Ser. No. 15/940,675, titled CLOUD        INTERFACE FOR COUPLED SURGICAL DEVICES.    -   U.S. patent application Ser. No. 15/940,627, titled DRIVE        ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS;    -   U.S. patent application Ser. No. 15/940,637, titled        COMMUNICATION ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL        PLATFORMS;    -   U.S. patent application Ser. No. 15/940,642, titled CONTROLS FOR        ROBOT-ASSISTED SURGICAL PLATFORMS;    -   U.S. patent application Ser. No. 15/940,676, titled AUTOMATIC        TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS;    -   U.S. patent application Ser. No. 15/940,680, titled CONTROLLERS        FOR ROBOT-ASSISTED SURGICAL PLATFORMS;    -   U.S. patent application Ser. No. 15/940,683, titled COOPERATIVE        SURGICAL ACTIONS FOR ROBOT-ASSISTED SURGICAL PLATFORMS;    -   U.S. patent application Ser. No. 15/940,690, titled DISPLAY        ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS; and    -   U.S. patent application Ser. No. 15/940,711, titled SENSING        ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS.

Applicant of the present application owns the following U.S. ProvisionalPatent Applications, filed on Mar. 28, 2018, the disclosure of each ofwhich is herein incorporated by reference in its entirety:

-   -   U.S. Provisional Patent Application Ser. No. 62/649,302, titled        INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION        CAPABILITIES;    -   U.S. Provisional Patent Application Ser. No. 62/649,294, titled        DATA STRIPPING METHOD TO INTERROGATE PATIENT RECORDS AND CREATE        ANONYMIZED RECORD;    -   U.S. Provisional Patent Application Ser. No. 62/649,300, titled        SURGICAL HUB SITUATIONAL AWARENESS;    -   U.S. Provisional Patent Application Ser. No. 62/649,309, titled        SURGICAL HUB SPATIAL AWARENESS TO DETERMINE DEVICES IN OPERATING        THEATER;    -   U.S. Provisional Patent Application Ser. No. 62/649,310, titled        COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS;    -   U.S. Provisional Patent Application Ser. No. 62/649,291, titled        USE OF LASER LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE        PROPERTIES OF BACK SCATTERED LIGHT;    -   U.S. Provisional Patent Application Ser. No. 62/649,296, titled        ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES;    -   U.S. Provisional Patent Application Ser. No. 62/649,333, titled        CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZATION AND        RECOMMENDATIONS TO A USER;    -   U.S. Provisional Patent Application Ser. No. 62/649,327, titled        CLOUD-BASED MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION        TRENDS AND REACTIVE MEASURES;    -   U.S. Provisional Patent Application Ser. No. 62/649,315, titled        DATA HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICS NETWORK;    -   U.S. Provisional Patent Application Ser. No. 62/649,313, titled        CLOUD INTERFACE FOR COUPLED SURGICAL DEVICES;    -   U.S. Provisional Patent Application Ser. No. 62/649,320, titled        DRIVE ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS;    -   U.S. Provisional Patent Application Ser. No. 62/649,307, titled        AUTOMATIC TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL        PLATFORMS; and    -   U.S. Provisional Patent Application Ser. No. 62/649,323, titled        SENSING ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS.

Applicant of the present application owns the following U.S. ProvisionalPatent Applications, filed on Mar. 8, 2018, the disclosure of each ofwhich is herein incorporated by reference in its entirety:

-   -   U.S. Provisional Patent Application Ser. No. 62/640,417, titled        TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM        THEREFOR; and    -   U.S. Provisional Patent Application Ser. No. 62/640,415, titled        ESTIMATING STATE OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM        THEREFOR.

Applicant of the present application owns the following U.S. ProvisionalPatent Applications, filed on Dec. 28, 2017, the disclosure of each ofwhich is herein incorporated by reference in its entirety:

-   -   U.S. Provisional Patent Application Serial No. U.S. Provisional        Patent Application Ser. No. 62/611,341, titled INTERACTIVE        SURGICAL PLATFORM;    -   U.S. Provisional Patent Application Ser. No. 62/611,340, titled        CLOUD-BASED MEDICAL ANALYTICS; and    -   U.S. Provisional Patent Application Ser. No. 62/611,339, titled        ROBOT ASSISTED SURGICAL PLATFORM.

Computer-Implemented Interactive Surgical System

Before explaining various aspects of surgical devices and generators indetail, it should be noted that the illustrative examples are notlimited in application or use to the details of construction andarrangement of parts illustrated in the accompanying drawings anddescription. The illustrative examples may be implemented orincorporated in other aspects, variations and modifications, and may bepracticed or carried out in various ways. Further, unless otherwiseindicated, the terms and expressions employed herein have been chosenfor the purpose of describing the illustrative examples for theconvenience of the reader and are not for the purpose of limitationthereof. Also, it will be appreciated that one or more of thefollowing-described aspects, expressions of aspects, and/or examples,can be combined with any one or more of the other following-describedaspects, expressions of aspects and/or examples.

Various aspects are directed to improved ultrasonic surgical devices,electrosurgical devices and generators for use therewith. Aspects of theultrasonic surgical devices can be configured for transecting and/orcoagulating tissue during surgical procedures, for example. Aspects ofthe electrosurgical devices can be configured for transecting,coagulating, scaling, welding and/or desiccating tissue during surgicalprocedures, for example.

Referring to FIG. 1, a computer-implemented interactive surgical system100 includes one or more surgical systems 102 and a cloud-based system(e.g., the cloud 104 that may include a remote server 113 coupled to astorage device 105). Each surgical system 102 includes at least onesurgical hub 106 in communication with the cloud 104 that may include aremote server 113. In one example, as illustrated in FIG. 1, thesurgical system 102 includes a visualization system 108, a roboticsystem 110, and a handheld intelligent surgical instrument 112, whichare configured to communicate with one another and/or the hub 106. Insome aspects, a surgical system 102 may include an M number of hubs 106,an N number of visualization systems 108, an O number of robotic systems110, and a P number of handheld intelligent surgical instruments 112,where M, N, O, and P are integers greater than or equal to one.

FIG. 3 depicts an example of a surgical system 102 being used to performa surgical procedure on a patient who is lying down on an operatingtable 114 in a surgical operating room 116. A robotic system 110 is usedin the surgical procedure as a part of the surgical system 102. Therobotic system 110 includes a surgeon's console 118, a patient side cart120 (surgical robot), and a surgical robotic hub 122. The patient sidecart 120 can manipulate at least one removably coupled surgical tool 117through a minimally invasive incision in the body of the patient whilethe surgeon views the surgical site through the surgeon's console 118.An image of the surgical site can be obtained by a medical imagingdevice 124, which can be manipulated by the patient side cart 120 toorient the imaging device 124. The robotic hub 122 can be used toprocess the images of the surgical site for subsequent display to thesurgeon through the surgeon's console 118.

Other types of robotic systems can be readily adapted for use with thesurgical system 102. Various examples of robotic systems and surgicaltools that are suitable for use with the present disclosure aredescribed in U.S. Provisional Patent Application Ser. No. 62/611,339,titled ROBOT ASSISTED SURGICAL PLATFORM, filed Dec. 28, 2017, thedisclosure of which is herein incorporated by reference in its entirety.

Various examples of cloud-based analytics that are performed by thecloud 104, and are suitable for use with the present disclosure, aredescribed in U.S. Provisional Patent Application Ser. No. 62/611,340,titled CLOUD-BASED MEDICAL ANALYTICS, filed Dec. 28, 2017, thedisclosure of which is herein incorporated by reference in its entirety.

In various aspects, the imaging device 124 includes at least one imagesensor and one or more optical components. Suitable image sensorsinclude, but are not limited to, Charge-Coupled Device (CCD) sensors andComplementary Metal-Oxide Semiconductor (CMOS) sensors.

The optical components of the imaging device 124 may include one or moreillumination sources and/or one or more lenses. The one or moreillumination sources may be directed to illuminate portions of thesurgical field. The one or more image sensors may receive lightreflected or refracted from the surgical field, including lightreflected or refracted from tissue and/or surgical instruments.

The one or more illumination sources may be configured to radiateelectromagnetic energy in the visible spectrum as well as the invisiblespectrum. The visible spectrum, sometimes referred to as the opticalspectrum or luminous spectrum, is that portion of the electromagneticspectrum that is visible to (i.e., can be detected by) the human eye andmay be referred to as visible light or simply light. A typical human eyewill respond to wavelengths in air that are from about 380 nm to about750 nm.

The invisible spectrum (i.e., the non-luminous spectrum) is that portionof the electromagnetic spectrum that lies below and above the visiblespectrum (i.e., wavelengths below about 380 nm and above about 750 nm).The invisible spectrum is not detectable by the human eye. Wavelengthsgreater than about 750 nm are longer than the red visible spectrum, andthey become invisible infrared (IR), microwave, and radioelectromagnetic radiation. Wavelengths less than about 380 nm areshorter than the violet spectrum, and they become invisible ultraviolet,x-ray, and gamma ray electromagnetic radiation.

In various aspects, the imaging device 124 is configured for use in aminimally invasive procedure. Examples of imaging devices suitable foruse with the present disclosure include, but not limited to, anarthroscope, angioscope, bronchoscope, choledochoscope, colonoscope,cytoscope, duodenoscope, enteroscope, esophagogastro-duodenoscope(gastroscope), endoscope, laryngoscope, nasopharyngo-neproscope,sigmoidoscope, thoracoscope, and ureteroscope.

In one aspect, the imaging device employs multi-spectrum monitoring todiscriminate topography and underlying structures. A multi-spectralimage is one that captures image data within specific wavelength rangesacross the electromagnetic spectrum. The wavelengths may be separated byfilters or by the use of instruments that are sensitive to particularwavelengths, including light from frequencies beyond the visible lightrange, e.g., IR and ultraviolet. Spectral imaging can allow extractionof additional information the human eye fails to capture with itsreceptors for red, green, and blue. The use of multi-spectral imaging isdescribed in greater detail under the heading “Advanced ImagingAcquisition Module” in U.S. Provisional Patent Application Ser. No.62/611,341, titled INTERACTIVE SURGICAL PLATFORM, filed Dec. 28, 2017,the disclosure of which is herein incorporated by reference in itsentirety. Multi-spectrum monitoring can be a useful tool in relocating asurgical field after a surgical task is completed to perform one or moreof the previously described tests on the treated tissue.

It is axiomatic that strict sterilization of the operating room andsurgical equipment is required during any surgery. The strict hygieneand sterilization conditions required in a “surgical theater,” i.e., anoperating or treatment room, necessitate the highest possible sterilityof all medical devices and equipment. Part of that sterilization processis the need to sterilize anything that comes in contact with the patientor penetrates the sterile field, including the imaging device 124 andits attachments and components. It will be appreciated that the sterilefield may be considered a specified area, such as within a tray or on asterile towel, that is considered free of microorganisms, or the sterilefield may be considered an area, immediately around a patient, who hasbeen prepared for a surgical procedure. The sterile field may includethe scrubbed team members, who are properly attired, and all furnitureand fixtures in the area.

In various aspects, the visualization system 108 includes one or moreimaging sensors, one or more image-processing units, one or more storagearrays, and one or more displays that are strategically arranged withrespect to the sterile field, as illustrated in FIG. 2. In one aspect,the visualization system 108 includes an interface for HL7, PACS, andEMR. Various components of the visualization system 108 are describedunder the heading “Advanced Imaging Acquisition Module” in U.S.Provisional Patent Application Ser. No. 62/611,341, titled INTERACTIVESURGICAL PLATFORM, filed Dec. 28, 2017, the disclosure of which isherein incorporated by reference in its entirety.

As illustrated in FIG. 2, a primary display 119 is positioned in thesterile field to be visible to an operator at the operating table 114.In addition, a visualization tower 111 is positioned outside the sterilefield. The visualization tower 111 includes a first non-sterile display107 and a second non-sterile display 109, which face away from eachother. The visualization system 108, guided by the hub 106, isconfigured to utilize the displays 107, 109, and 119 to coordinateinformation flow to operators inside and outside the sterile field. Forexample, the hub 106 may cause the visualization system 108 to display asnapshot of a surgical site, as recorded by an imaging device 124, on anon-sterile display 107 or 109, while maintaining a live feed of thesurgical site on the primary display 119. The snapshot on thenon-sterile display 107 or 109 can permit a non-sterile operator toperform a diagnostic step relevant to the surgical procedure, forexample.

In one aspect, the hub 106 is also configured to route a diagnosticinput or feedback entered by a non-sterile operator at the visualizationtower 111 to the primary display 119 within the sterile field, where itcan be viewed by a sterile operator at the operating table. In oneexample, the input can be in the form of a modification to the snapshotdisplayed on the non-sterile display 107 or 109, which can be routed tothe primary display 119 by the hub 106.

Referring to FIG. 2, a surgical instrument 112 is being used in thesurgical procedure as part of the surgical system 102. The hub 106 isalso configured to coordinate information flow to a display of thesurgical instrument 112. For example, in U.S. Provisional PatentApplication Ser. No. 62/611,341, titled INTERACTIVE SURGICAL PLATFORM,filed Dec. 28, 2017, the disclosure of which is herein incorporated byreference in its entirety. A diagnostic input or feedback entered by anon-sterile operator at the visualization tower 111 can be routed by thehub 106 to the surgical instrument display 115 within the sterile field,where it can be viewed by the operator of the surgical instrument 112.Example surgical instruments that are suitable for use with the surgicalsystem 102 are described under the heading “Surgical InstrumentHardware” and in U.S. Provisional Patent Application Ser. No.62/611,341, titled INTERACTIVE SURGICAL PLATFORM, filed Dec. 28, 2017,the disclosure of which is herein incorporated by reference in itsentirety, for example.

Referring now to FIG. 3, a hub 106 is depicted in communication with avisualization system 108, a robotic system 110, and a handheldintelligent surgical instrument 112. The hub 106 includes a hub display135, an imaging module 138, a generator module 140, a communicationmodule 130, a processor module 132, and a storage array 134. In certainaspects, as illustrated in FIG. 3, the hub 106 further includes a smokeevacuation module 126 and/or a suction/irrigation module 128.

During a surgical procedure, energy application to tissue, for sealingand/or cutting, is generally associated with smoke evacuation, suctionof excess fluid, and/or irrigation of the tissue. Fluid, power, and/ordata lines from different sources are often entangled during thesurgical procedure. Valuable time can be lost addressing this issueduring a surgical procedure. Detangling the lines may necessitatedisconnecting the lines from their respective modules, which may requireresetting the modules. The hub modular enclosure 136 offers a unifiedenvironment for managing the power, data, and fluid lines, which reducesthe frequency of entanglement between such lines.

Aspects of the present disclosure present a surgical hub for use in asurgical procedure that involves energy application to tissue at asurgical site. The surgical hub includes a hub enclosure and a combogenerator module slidably receivable in a docking station of the hubenclosure. The docking station includes data and power contacts. Thecombo generator module includes two or more of an ultrasonic energygenerator component, a bipolar RF energy generator component, and amonopolar RF energy generator component that are housed in a singleunit. In one aspect, the combo generator module also includes a smokeevacuation component, at least one energy delivery cable for connectingthe combo generator module to a surgical instrument, at least one smokeevacuation component configured to evacuate smoke, fluid, and/orparticulates generated by the application of therapeutic energy to thetissue, and a fluid line extending from the remote surgical site to thesmoke evacuation component.

In one aspect, the fluid line is a first fluid line and a second fluidline extends from the remote surgical site to a suction and irrigationmodule slidably received in the hub enclosure. In one aspect, the hubenclosure comprises a fluid interface.

Certain surgical procedures may require the application of more than oneenergy type to the tissue. One energy type may be more beneficial forcutting the tissue, while another different energy type may be morebeneficial for sealing the tissue. For example, a bipolar generator canbe used to seal the tissue while an ultrasonic generator can be used tocut the sealed tissue. Aspects of the present disclosure present asolution where a hub modular enclosure 136 is configured to accommodatedifferent generators, and facilitate an interactive communicationtherebetween. One of the advantages of the hub modular enclosure 136 isenabling the quick removal and/or replacement of various modules.

Aspects of the present disclosure present a modular surgical enclosurefor use in a surgical procedure that involves energy application totissue. The modular surgical enclosure includes a first energy-generatormodule, configured to generate a first energy for application to thetissue, and a first docking station comprising a first docking port thatincludes first data and power contacts, wherein the firstenergy-generator module is slidably movable into an electricalengagement with the power and data contacts and wherein the firstenergy-generator module is slidably movable out of the electricalengagement with the first power and data contacts,

Further to the above, the modular surgical enclosure also includes asecond energy-generator module configured to generate a second energy,different than the first energy, for application to the tissue, and asecond docking station comprising a second docking port that includessecond data and power contacts, wherein the second energy-generatormodule is slidably movable into an electrical engagement with the powerand data contacts, and wherein the second energy-generator module isslidably movable out of the electrical engagement with the second powerand data contacts.

In addition, the modular surgical enclosure also includes acommunication bus between the first docking port and the second dockingport, configured to facilitate communication between the firstenergy-generator module and the second energy-generator module.

Referring to FIGS. 3-7, aspects of the present disclosure are presentedfor a hub modular enclosure 136 that allows the modular integration of agenerator module 140, a smoke evacuation module 126, and asuction/irrigation module 128. The hub modular enclosure 136 furtherfacilitates interactive communication between the modules 140, 126, 128.As illustrated in FIG. 5, the generator module 140 can be a generatormodule with integrated monopolar, bipolar, and ultrasonic componentssupported in a single housing unit 139 slidably insertable into the hubmodular enclosure 136. As illustrated in FIG. 5, the generator module140 can be configured to connect to a monopolar device 146, a bipolardevice 147, and an ultrasonic device 148. Alternatively, the generatormodule 140 may comprise a series of monopolar, bipolar, and/orultrasonic generator modules that interact through the hub modularenclosure 136. The hub modular enclosure 136 can be configured tofacilitate the insertion of multiple generators and interactivecommunication between the generators docked into the hub modularenclosure 136 so that the generators would act as a single generator.

In one aspect, the hub modular enclosure 136 comprises a modular powerand communication backplane 149 with external and wireless communicationheaders to enable the removable attachment of the modules 140, 126, 128and interactive communication therebetween.

In one aspect, the hub modular enclosure 136 includes docking stations,or drawers, 151, herein also referred to as drawers, which areconfigured to slidably receive the modules 140, 126, 128. FIG. 4illustrates a partial perspective view of a surgical hub enclosure 136,and a combo generator module 145 slidably receivable in a dockingstation 151 of the surgical hub enclosure 136. A docking port 152 withpower and data contacts on a rear side of the combo generator module 145is configured to engage a corresponding docking port 150 with power anddata contacts of a corresponding docking station 151 of the hub modularenclosure 136 as the combo generator module 145 is slid into positionwithin the corresponding docking station 151 of the hub module enclosure136. In one aspect, the combo generator module 145 includes a bipolar,ultrasonic, and monopolar module and a smoke evacuation moduleintegrated together into a single housing unit 139, as illustrated inFIG. 5.

In various aspects, the smoke evacuation module 126 includes a fluidline 154 that conveys captured/collected smoke and/or fluid away from asurgical site and to, for example, the smoke evacuation module 126.Vacuum suction originating from the smoke evacuation module 126 can drawthe smoke into an opening of a utility conduit at the surgical site. Theutility conduit, coupled to the fluid line, can be in the form of aflexible tube terminating at the smoke evacuation module 126. Theutility conduit and the fluid line define a fluid path extending towardthe smoke evacuation module 126 that is received in the hub enclosure136.

In various aspects, the suction/irrigation module 128 is coupled to asurgical tool comprising an aspiration fluid line and a suction fluidline. In one example, the aspiration and suction fluid lines are in theform of flexible tubes extending from the surgical site toward thesuction/irrigation module 128. One or more drive systems can beconfigured to cause irrigation and aspiration of fluids to and from thesurgical site.

In one aspect, the surgical tool includes a shaft having an end effectorat a distal end thereof and at least one energy treatment associatedwith the end effector, an aspiration tube, and an irrigation tube. Theaspiration tube can have an inlet port at a distal end thereof and theaspiration tube extends through the shaft. Similarly, an irrigation tubecan extend through the shaft and can have an inlet port in proximity tothe energy deliver implement. The energy deliver implement is configuredto deliver ultrasonic and/or RF energy to the surgical site and iscoupled to the generator module 140 by a cable extending initiallythrough the shaft.

The irrigation tube can be in fluid communication with a fluid source,and the aspiration tube can be in fluid communication with a vacuumsource. The fluid source and/or the vacuum source can be housed in thesuction/irrigation module 128. In one example, the fluid source and/orthe vacuum source can be housed in the hub enclosure 136 separately fromthe suction/irrigation module 128. In such example, a fluid interfacecan be configured to connect the suction/irrigation module 128 to thefluid source and/or the vacuum source.

In one aspect, the modules 140, 126, 128 and/or their correspondingdocking stations on the hub modular enclosure 136 may include alignmentfeatures that are configured to align the docking ports of the modulesinto engagement with their counterparts in the docking stations of thehub modular enclosure 136. For example, as illustrated in FIG. 4, thecombo generator module 145 includes side brackets 155 that areconfigured to slidably engage with corresponding brackets 156 of thecorresponding docking station 151 of the hub modular enclosure 136. Thebrackets cooperate to guide the docking port contacts of the combogenerator module 145 into an electrical engagement with the docking portcontacts of the hub modular enclosure 136.

In some aspects, the drawers 151 of the hub modular enclosure 136 arethe same, or substantially the same size, and the modules are adjustedin size to be received in the drawers 151. For example, the sidebrackets 155 and/or 156 can be larger or smaller depending on the sizeof the module. In other aspects, the drawers 151 are different in sizeand are each designed to accommodate a particular module.

Furthermore, the contacts of a particular module can be keyed forengagement with the contacts of a particular drawer to avoid inserting amodule into a drawer with mismatching contacts.

As illustrated in FIG. 4, the docking port 150 of one drawer 151 can becoupled to the docking port 150 of another drawer 151 through acommunications link 157 to facilitate an interactive communicationbetween the modules housed in the hub modular enclosure 136. The dockingports 150 of the hub modular enclosure 136 may alternatively, oradditionally, facilitate a wireless interactive communication betweenthe modules housed in the hub modular enclosure 136. Any suitablewireless communication can be employed, such as for example AirTitan-Bluetooth.

FIG. 6 illustrates a surgical data network 201 comprising a modularcommunication hub 203 configured to connect modular devices located inone or more operating theaters of a healthcare facility, or any room ina healthcare facility specially equipped for surgical operations, to acloud-based system (e.g., the cloud 204 that may include a remote server213 coupled to a storage device 205). In one aspect, the modularcommunication hub 203 comprises a network hub 207 and/or a networkswitch 209 in communication with a network router. The modularcommunication hub 203 also can be coupled to a local computer system 210to provide local computer processing and data manipulation. The surgicaldata network 201 may be configured as passive, intelligent, orswitching. A passive surgical data network serves as a conduit for thedata, enabling it to go from one device (or segment) to another and tothe cloud computing resources. An intelligent surgical data networkincludes additional features to enable the traffic passing through thesurgical data network to be monitored and to configure each port in thenetwork hub 207 or network switch 209. An intelligent surgical datanetwork may be referred to as a manageable hub or switch. A switchinghub reads the destination address of each packet and then forwards thepacket to the correct port.

Modular devices 1 a-1 n located in the operating theater may be coupledto the modular communication hub 203. The network hub 207 and/or thenetwork switch 209 may be coupled to a network router 211 to connect thedevices 1 a-1 n to the cloud 204 or the local computer system 210. Dataassociated with the devices 1 a-1 n may be transferred to cloud-basedcomputers via the router for remote data processing and manipulation.Data associated with the devices 1 a-1 n may also be transferred to thelocal computer system 210 for local data processing and manipulation.Modular devices 2 a-2 m located in the same operating theater also maybe coupled to a network switch 209. The network switch 209 may becoupled to the network hub 207 and/or the network router 211 to connectto the devices 2 a-2 m to the cloud 204. Data associated with thedevices 2 a-2 n may be transferred to the cloud 204 via the networkrouter 211 for data processing and manipulation. Data associated withthe devices 2 a-2 m may also be transferred to the local computer system210 for local data processing and manipulation.

It will be appreciated that the surgical data network 201 may beexpanded by interconnecting multiple network hubs 207 and/or multiplenetwork switches 209 with multiple network routers 211. The modularcommunication hub 203 may be contained in a modular control towerconfigured to receive multiple devices 1 a-1 n/2 a-2 m. The localcomputer system 210 also may be contained in a modular control tower.The modular communication hub 203 is connected to a display 212 todisplay images obtained by some of the devices 1 a-1 n/2 a-2 m, forexample during surgical procedures. In various aspects, the devices 1a-1 n/2 a-2 m may include, for example, various modules such as animaging module 138 coupled to an endoscope, a generator module 140coupled to an energy-based surgical device, a smoke evacuation module126, a suction/irrigation module 128, a communication module 130, aprocessor module 132, a storage array 134, a surgical device coupled toa display, and/or a non-contact sensor module, among other modulardevices that may be connected to the modular communication hub 203 ofthe surgical data network 201.

In one aspect, the surgical data network 201 may comprise a combinationof network hub(s), network switch(es), and network router(s) connectingthe devices 1 a-1 n/2 a-2 m to the cloud. Any one of or all of thedevices 1 a-1 n/2 a-2 m coupled to the network hub or network switch maycollect data in real time and transfer the data to cloud computers fordata processing and manipulation. It will be appreciated that cloudcomputing relies on sharing computing resources rather than having localservers or personal devices to handle software applications. The word“cloud” may be used as a metaphor for “the Internet,” although the termis not limited as such. Accordingly, the term “cloud computing” may beused herein to refer to “a type of Internet-based computing,” wheredifferent services—such as servers, storage, and applications—aredelivered to the modular communication hub 203 and/or computer system210 located in the surgical theater (e.g., a fixed, mobile, temporary,or field operating room or space) and to devices connected to themodular communication hub 203 and/or computer system 210 through theInternet. The cloud infrastructure may be maintained by a cloud serviceprovider. In this context, the cloud service provider may be the entitythat coordinates the usage and control of the devices 1 a-1 n/2 a-2 mlocated in one or more operating theaters. The cloud computing servicescan perform a large number of calculations based on the data gathered bysmart surgical instruments, robots, and other computerized deviceslocated in the operating theater. The hub hardware enables multipledevices or connections to be connected to a computer that communicateswith the cloud computing resources and storage.

Applying cloud computer data processing techniques on the data collectedby the devices 1 a-1 n/2 a-2 m, the surgical data network providesimproved surgical outcomes, reduced costs, and improved patientsatisfaction. At least some of the devices 1 a-1 n/2 a-2 m may beemployed to view tissue states to assess leaks or perfusion of sealedtissue after a tissue sealing and cutting procedure. At least some ofthe devices 1 a-1 n/2 a-2 m may be employed to identify pathology, suchas the effects of diseases, using the cloud-based computing to examinedata including images of samples of body tissue for diagnostic purposes.This includes localization and margin confirmation of tissue andphenotypes. At least some of the devices 1 a-1 n/2 a-2 m may be employedto identify anatomical structures of the body using a variety of sensorsintegrated with imaging devices and techniques such as overlaying imagescaptured by multiple imaging devices. The data gathered by the devices 1a-1 n/2 a-2 m, including image data, may be transferred to the cloud 204or the local computer system 210 or both for data processing andmanipulation including image processing and manipulation. The data maybe analyzed to improve surgical procedure outcomes by determining iffurther treatment, such as the application of endoscopic intervention,emerging technologies, a targeted radiation, targeted intervention, andprecise robotics to tissue-specific sites and conditions, may bepursued. Such data analysis may further employ outcome analyticsprocessing, and using standardized approaches may provide beneficialfeedback to either confirm surgical treatments and the behavior of thesurgeon or suggest modifications to surgical treatments and the behaviorof the surgeon.

In one implementation, the operating theater devices 1 a-1 n may beconnected to the modular communication hub 203 over a wired channel or awireless channel depending on the configuration of the devices 1 a-1 nto a network hub. The network hub 207 may be implemented, in one aspect,as a local network broadcast device that works on the physical layer ofthe Open System Interconnection (OSI) model. The network hub providesconnectivity to the devices 1 a-1 n located in the same operatingtheater network. The network hub 207 collects data in the form ofpackets and sends them to the router in half duplex mode. The networkhub 207 does not store any media access control/Internet Protocol(MAC/IP) to transfer the device data. Only one of the devices 1 a-1 ncan send data at a time through the network hub 207. The network hub 207has no routing tables or intelligence regarding where to sendinformation and broadcasts all network data across each connection andto a remote server 213 (FIG. 7) over the cloud 204. The network hub 207can detect basic network errors such as collisions, but having allinformation broadcast to multiple ports can be a security risk and causebottlenecks.

In another implementation, the operating theater devices 2 a-2 m may beconnected to a network switch 209 over a wired channel or a wirelesschannel. The network switch 209 works in the data link layer of the OSImodel. The network switch 209 is a multicast device for connecting thedevices 2 a-2 m located in the same operating theater to the network.The network switch 209 sends data in the form of frames to the networkrouter 211 and works in full duplex mode. Multiple devices 2 a-2 m cansend data at the same time through the network switch 209. The networkswitch 209 stores and uses MAC addresses of the devices 2 a-2 m totransfer data.

The network hub 207 and/or the network switch 209 are coupled to thenetwork router 211 for connection to the cloud 204. The network router211 works in the network layer of the OSI model. The network router 211creates a route for transmitting data packets received from the networkhub 207 and/or network switch 211 to cloud-based computer resources forfurther processing and manipulation of the data collected by any one ofor all the devices 1 a-1 n/2 a-2 m. The network router 211 may beemployed to connect two or more different networks located in differentlocations, such as, for example, different operating theaters of thesame healthcare facility or different networks located in differentoperating theaters of different healthcare facilities. The networkrouter 211 sends data in the form of packets to the cloud 204 and worksin full duplex mode. Multiple devices can send data at the same time.The network router 211 uses IP addresses to transfer data.

In one example, the network hub 207 may be implemented as a USB hub,which allows multiple USB devices to be connected to a host computer.The USB hub may expand a single USB port into several tiers so thatthere are more ports available to connect devices to the host systemcomputer. The network hub 207 may include wired or wireless capabilitiesto receive information over a wired channel or a wireless channel. Inone aspect, a wireless USB short-range, high-bandwidth wireless radiocommunication protocol may be employed for communication between thedevices 1 a-1 n and devices 2 a-2 m located in the operating theater.

In other examples, the operating theater devices 1 a-1 n/2 a-2 m maycommunicate to the modular communication hub 203 via Bluetooth wirelesstechnology standard for exchanging data over short distances (usingshort-wavelength UHF radio waves in the ISM band from 2.4 to 2.485 GHz)from fixed and mobile devices and building personal area networks(PANs). In other aspects, the operating theater devices 1 a-1 n/2 a-2 mmay communicate to the modular communication hub 203 via a number ofwireless or wired communication standards or protocols, including butnot limited to Wi-Fi (IEEE 802.11 family), WiMAX (IEEE 802.16 family),IEEE 802.20, long-term evolution (LTE), and Ev-DO, HSPA+, HSDPA+,HSUPA+, EDGE, GSM, GPRS, CDMA, TDMA, DECT, and Ethernet derivativesthereof, as well as any other wireless and wired protocols that aredesignated as 3G, 4G, 5G, and beyond. The computing module may include aplurality of communication modules. For instance, a first communicationmodule may be dedicated to shorter-range wireless communications such asWi-Fi and Bluetooth, and a second communication module may be dedicatedto longer-range wireless communications such as GPS, EDGE, GPRS, CDMA,WiMAX, LTE, Ev-DO, and others.

The modular communication hub 203 may serve as a central connection forone or all of the operating theater devices 1 a-1 n/2 a-2 m and handlesa data type known as frames. Frames carry the data generated by thedevices 1 a-1 n/2 a-2 m. When a frame is received by the modularcommunication hub 203, it is amplified and transmitted to the networkrouter 211, which transfers the data to the cloud computing resources byusing a number of wireless or wired communication standards orprotocols, as described herein.

The modular communication hub 203 can be used as a standalone device orbe connected to compatible network hubs and network switches to form alarger network. The modular communication hub 203 is generally easy toinstall, configure, and maintain, making it a good option for networkingthe operating theater devices 1 a-1 n/2 a-2 m.

FIG. 7 illustrates a computer-implemented interactive surgical system200. The computer-implemented interactive surgical system 200 is similarin many respects to the computer-implemented interactive surgical system100. For example, the computer-implemented interactive surgical system200 includes one or more surgical systems 202, which are similar in manyrespects to the surgical systems 102. Each surgical system 202 includesat least one surgical hub 206 in communication with a cloud 204 that mayinclude a remote server 213. In one aspect, the computer-implementedinteractive surgical system 200 comprises a modular control tower 236connected to multiple operating theater devices such as, for example,intelligent surgical instruments, robots, and other computerized deviceslocated in the operating theater. As shown in FIG. 8, the modularcontrol tower 236 comprises a modular communication hub 203 coupled to acomputer system 210. As illustrated in the example of FIG. 7, themodular control tower 236 is coupled to an imaging module 238 that iscoupled to an endoscope 239, a generator module 240 that is coupled toan energy device 241, a smoke evacuator module 226, a suction/irrigationmodule 228, a communication module 230, a processor module 232, astorage array 234, a smart device/instrument 235 optionally coupled to adisplay 237, and a non-contact sensor module 242. The operating theaterdevices are coupled to cloud computing resources and data storage viathe modular control tower 236. A robot hub 222 also may be connected tothe modular control tower 236 and to the cloud computing resources. Thedevices/instruments 235, visualization systems 208, among others, may becoupled to the modular control tower 236 via wired or wirelesscommunication standards or protocols, as described herein. The modularcontrol tower 236 may be coupled to a hub display 215 (e.g., monitor,screen) to display and overlay images received from the imaging module,device/instrument display, and/or other visualization systems 208. Thehub display also may display data received from devices connected to themodular control tower in conjunction with images and overlaid images.

FIG. 8 illustrates a surgical hub 206 comprising a plurality of modulescoupled to the modular control tower 236. The modular control tower 236comprises a modular communication hub 203, e.g., a network connectivitydevice, and a computer system 210 to provide local processing,visualization, and imaging, for example. As shown in FIG. 8, the modularcommunication hub 203 may be connected in a tiered configuration toexpand the number of modules (e.g., devices) that may be connected tothe modular communication hub 203 and transfer data associated with themodules to the computer system 210, cloud computing resources, or both.As shown in FIG. 8, each of the network hubs/switches in the modularcommunication hub 203 includes three downstream ports and one upstreamport. The upstream network hub/switch is connected to a processor toprovide a communication connection to the cloud computing resources anda local display 217. Communication to the cloud 204 may be made eitherthrough a wired or a wireless communication channel.

The surgical hub 206 employs a non-contact sensor module 242 to measurethe dimensions of the operating theater and generate a map of thesurgical theater using either ultrasonic or laser-type non-contactmeasurement devices. An ultrasound-based non-contact sensor module scansthe operating theater by transmitting a burst of ultrasound andreceiving the echo when it bounces off the perimeter walls of anoperating theater as described under the heading “Surgical Hub SpatialAwareness Within an Operating Room” in U.S. Provisional PatentApplication Ser. No. 62/611,341, titled INTERACTIVE SURGICAL PLATFORM,filed Dec. 28, 2017, which is herein incorporated by reference in itsentirety, in which the sensor module is configured to determine the sizeof the operating theater and to adjust Bluetooth-pairing distancelimits. A laser-based non-contact sensor module scans the operatingtheater by transmitting laser light pulses, receiving laser light pulsesthat bounce off the perimeter walls of the operating theater, andcomparing the phase of the transmitted pulse to the received pulse todetermine the size of the operating theater and to adjust Bluetoothpairing distance limits, for example.

The computer system 210 comprises a processor 244 and a networkinterface 245. The processor 244 is coupled to a communication module247, storage 248, memory 249, non-volatile memory 250, and input/outputinterface 251 via a system bus. The system bus can be any of severaltypes of bus structure(s) including the memory bus or memory controller,a peripheral bus or external bus, and/or a local bus using any varietyof available bus architectures including, but not limited to, 9-bit bus,Industrial Standard Architecture (ISA), Micro-Charmel Architecture(MSA), Extended ISA (EISA), Intelligent Drive Electronics (IDE), VESALocal Bus (VLB), Peripheral Component Interconnect (PCI), USB, AdvancedGraphics Port (AGP), Personal Computer Memory Card InternationalAssociation bus (PCMCIA), Small Computer Systems Interface (SCSI), orany other proprietary bus.

The processor 244 may be any single-core or multicore processor such asthose known under the trade name ARM Cortex by Texas Instruments. In oneaspect, the processor may be an LM4F230H5QR ARM Cortex-M4F ProcessorCore, available from Texas Instruments, for example, comprising anon-chip memory of 256 KB single-cycle flash memory, or othernon-volatile memory, up to 40 MHz, a prefetch buffer to improveperformance above 40 MHz, a 32 KB single-cycle serial random accessmemory (SRAM), an internal read-only memory (ROM) loaded withStellarisWare® software, a 2 KB electrically erasable programmableread-only memory (EEPROM), and/or one or more pulse width modulation(PWM) modules, one or more quadrature encoder inputs (QEI) analogs, oneor more 12-bit analog-to-digital converters (ADCs) with 12 analog inputchannels, details of which are available for the product datasheet.

In one aspect, the processor 244 may comprise a safety controllercomprising two controller-based families such as TMS570 and RM4x, knownunder the trade name Hercules ARM Cortex R4, also by Texas Instruments.The safety controller may be configured specifically for IEC 61508 andISO 26262 safety critical applications, among others, to provideadvanced integrated safety features while delivering scalableperformance, connectivity, and memory options.

The system memory includes volatile memory and non-volatile memory. Thebasic input/output system (BIOS), containing the basic routines totransfer information between elements within the computer system, suchas during start-up, is stored in non-volatile memory. For example, thenon-volatile memory can include ROM, programmable ROM (PROM),electrically programmable ROM (EPROM), EEPROM, or flash memory. Volatilememory includes random-access memory (RAM), which acts as external cachememory. Moreover, RAM is available in many forms such as SRAM, dynamicRAM (DRAM), synchronous DRAM (SDRAM), double data rate SDRAM (DDRSDRAM), enhanced SDRAM (ESDRAM), Synchlink DRAM (SLDRAM), and directRambus RAM (DRRAM).

The computer system 210 also includes removable/non-removable,volatile/non-volatile computer storage media, such as for example diskstorage. The disk storage includes, but is not limited to, devices likea magnetic disk drive, floppy disk drive, tape drive, Jaz drive, Zipdrive, LS-60 drive, flash memory card, or memory stick. In addition, thedisk storage can include storage media separately or in combination withother storage media including, but not limited to, an optical disc drivesuch as a compact disc ROM device (CD-ROM), compact disc recordabledrive (CD-R Drive), compact disc rewritable drive (CD-RW Drive), or adigital versatile disc ROM drive (DVD-ROM). To facilitate the connectionof the disk storage devices to the system bus, a removable ornon-removable interface may be employed.

It is to be appreciated that the computer system 210 includes softwarethat acts as an intermediary between users and the basic computerresources described in a suitable operating environment. Such softwareincludes an operating system. The operating system, which can be storedon the disk storage, acts to control and allocate resources of thecomputer system. System applications take advantage of the management ofresources by the operating system through program modules and programdata stored either in the system memory or on the disk storage. It is tobe appreciated that various components described herein can beimplemented with various operating systems or combinations of operatingsystems.

A user enters commands or information into the computer system 210through input device(s) coupled to the I/O interface 251. The inputdevices include, but are not limited to, a pointing device such as amouse, trackball, stylus, touch pad, keyboard, microphone, joystick,game pad, satellite dish, scanner, TV tuner card, digital camera,digital video camera, web camera, and the like. These and other inputdevices connect to the processor through the system bus via interfaceport(s). The interface port(s) include, for example, a serial port, aparallel port, a game port, and a USB. The output device(s) use some ofthe same types of ports as input device(s). Thus, for example, a USBport may be used to provide input to the computer system and to outputinformation from the computer system to an output device. An outputadapter is provided to illustrate that there are some output deviceslike monitors, displays, speakers, and printers, among other outputdevices that require special adapters. The output adapters include, byway of illustration and not limitation, video and sound cards thatprovide a means of connection between the output device and the systembus. It should be noted that other devices and/or systems of devices,such as remote computer(s), provide both input and output capabilities.

The computer system 210 can operate in a networked environment usinglogical connections to one or more remote computers, such as cloudcomputer(s), or local computers. The remote cloud computer(s) can be apersonal computer, server, router, network PC, workstation,microprocessor-based appliance, peer device, or other common networknode, and the like, and typically includes many or all of the elementsdescribed relative to the computer system. For purposes of brevity, onlya memory storage device is illustrated with the remote computer(s). Theremote computer(s) is logically connected to the computer system througha network interface and then physically connected via a communicationconnection. The network interface encompasses communication networkssuch as local area networks (LANs) and wide area networks (WANs). LANtechnologies include Fiber Distributed Data Interface (FDDI), CopperDistributed Data Interface (CDDI), Ethernet/IEEE 802.3, Token Ring/IEEE802.5 and the like. WAN technologies include, but are not limited to,point-to-point links, circuit-switching networks like IntegratedServices Digital Networks (ISDN) and variations thereon,packet-switching networks, and Digital Subscriber Lines (DSL).

In various aspects, the computer system 210 of FIG. 8, the imagingmodule 238 and/or visualization system 208, and/or the processor module232 of FIGS. 9-10, may comprise an image processor, image-processingengine, media processor, or any specialized digital signal processor(DSP) used for the processing of digital images. The image processor mayemploy parallel computing with single instruction, multiple data (SIMD)or multiple instruction, multiple data (MIMD) technologies to increasespeed and efficiency. The digital image-processing engine can perform arange of tasks. The image processor may be a system on a chip withmulticore processor architecture.

The communication connection(s) refers to the hardware/software employedto connect the network interface to the bus. While the communicationconnection is shown for illustrative clarity inside the computer system,it can also be external to the computer system 210. Thehardware/software necessary for connection to the network interfaceincludes, for illustrative purposes only, internal and externaltechnologies such as modems, including regular telephone-grade modems,cable modems, and DSL modems, ISDN adapters, and Ethernet cards.

FIG. 9 illustrates a functional block diagram of one aspect of a USBnetwork hub 300 device, in accordance with at least one aspect of thepresent disclosure. In the illustrated aspect, the USB network hubdevice 300 employs a TUSB2036 integrated circuit hub by TexasInstruments. The USB network hub 300 is a CMOS device that provides anupstream USB transceiver port 302 and up to three downstream USBtransceiver ports 304, 306, 308 in compliance with the USB 2.0specification. The upstream USB transceiver port 302 is a differentialroot data port comprising a differential data minus (DM0) input pairedwith a differential data plus (DP0) input. The three downstream USBtransceiver ports 304, 306, 308 are differential data ports where eachport includes differential data plus (DP1−DP3) outputs paired withdifferential data minus (DM1−DM3) outputs.

The USB network hub 300 device is implemented with a digital statemachine instead of a microcontroller, and no firmware programming isrequired. Fully compliant USB transceivers are integrated into thecircuit for the upstream USB transceiver port 302 and all downstream USBtransceiver ports 304, 306, 308. The downstream USB transceiver ports304, 306, 308 support both full-speed and low-speed devices byautomatically setting the slew rate according to the speed of the deviceattached to the ports. The USB network hub 300 device may be configuredeither in bus-powered or self-powered mode and includes a hub powerlogic 312 to manage power.

The USB network hub 300 device includes a serial interface engine 310(SIE). The SIE 310 is the front end of the USB network hub 300 hardwareand handles most of the protocol described in chapter 8 of the USBspecification. The SIE 310 typically comprehends signaling up to thetransaction level. The functions that it handles could include: packetrecognition, transaction sequencing, SOP, EOP, RESET, and RESUME signaldetection/generation, clock/data separation, non-return-to-zero invert(NRZI) data encoding/decoding and bit-stuffing, CRC generation andchecking (token and data), packet ID (PID) generation andchecking/decoding, and/or serial-parallel/parallel-serial conversion.The 310 receives a clock input 314 and is coupled to a suspend/resumelogic and frame timer 316 circuit and a hub repeater circuit 318 tocontrol communication between the upstream USB transceiver port 302 andthe downstream USB transceiver ports 304, 306, 308 through port logiccircuits 320, 322, 324. The SIE 310 is coupled to a command decoder 326via interface logic to control commands from a serial EEPROM via aserial EEPROM interface 330.

In various aspects, the USB network hub 300 can connect 127 functionsconfigured in up to six logical layers (tiers) to a single computer.Further, the USB network hub 300 can connect to all peripherals using astandardized four-wire cable that provides both communication and powerdistribution. The power configurations are bus-powered and self-poweredmodes. The USB network hub 300 may be configured to support four modesof power management: a bus-powered hub, with either individual-portpower management or ganged-port power management, and the self-poweredhub, with either individual-port power management or ganged-port powermanagement. In one aspect, using a USB cable, the USB network hub 300,the upstream USB transceiver port 302 is plugged into a USB hostcontroller, and the downstream USB transceiver ports 304, 306, 308 areexposed for connecting USB compatible devices, and so forth.

Surgical Instrument Hardware

FIG. 10 illustrates a logic diagram of a control system 470 of asurgical instrument or tool in accordance with one or more aspects ofthe present disclosure. The system 470 comprises a control circuit. Thecontrol circuit includes a microcontroller 461 comprising a processor462 and a memory 468. One or more of sensors 472, 474, 476, for example,provide real-time feedback to the processor 462. A motor 482, driven bya motor driver 492, operably couples a longitudinally movabledisplacement member to drive a clamp arm closure member. A trackingsystem 480 is configured to determine the position of the longitudinallymovable displacement member. The position information is provided to theprocessor 462, which can be programmed or configured to determine theposition of the longitudinally movable drive member as well as theposition of the closure member. Additional motors may be provided at thetool driver interface to control closure tube travel, shaft rotation,articulation, or clamp arm closure, or a combination of the above. Adisplay 473 displays a variety of operating conditions of theinstruments and may include touch screen functionality for data input.Information displayed on the display 473 may be overlaid with imagesacquired via endoscopic imaging modules.

In one aspect, the microcontroller 461 may be any single-core ormulticore processor such as those known under the trade name ARM Cortexby Texas Instruments. In one aspect, the main microcontroller 461 may bean LM4F230H5QR ARM Cortex-M4F Processor Core, available from TexasInstruments, for example, comprising an on-chip memory of 256 KBsingle-cycle flash memory, or other non-volatile memory, up to 40 MHz, aprefetch buffer to improve performance above 40 MHz, a 32 KBsingle-cycle SRAM, and internal ROM loaded with StellarisWare® software,a 2 KB EEPROM, one or more PWM modules, one or more QEI analogs, and/orone or more 12-bit ADCs with 12 analog input channels, details of whichare available for the product datasheet.

In one aspect, the microcontroller 461 may comprise a safety controllercomprising two controller-based families such as TMS570 and RM4x, knownunder the trade name Hercules ARM Cortex R4, also by Texas Instruments.The safety controller may be configured specifically for IEC 61508 andISO 26262 safety critical applications, among others, to provideadvanced integrated safety features while delivering scalableperformance, connectivity, and memory options.

The microcontroller 461 may be programmed to perform various functionssuch as precise control over the speed and position of the knife,articulation systems, clamp arm, or a combination of the above. In oneaspect, the microcontroller 461 includes a processor 462 and a memory468. The electric motor 482 may be a brushed direct current (DC) motorwith a gearbox and mechanical links to an articulation or knife system.In one aspect, a motor driver 492 may be an A3941 available from AllegroMicrosystems, Inc. Other motor drivers may be readily substituted foruse in the tracking system 480 comprising an absolute positioningsystem. A detailed description of an absolute positioning system isdescribed in U.S. Patent Application Publication No. 2017/0296213,titled SYSTEMS AND METHODS FOR CONTROLLING A SURGICAL STAPLING ANDCUTTING INSTRUMENT, which published on Oct. 19, 2017, which is hereinincorporated by reference in its entirety.

The microcontroller 461 may be programmed to provide precise controlover the speed and position of displacement members and articulationsystems. The microcontroller 461 may be configured to compute a responsein the software of the microcontroller 461. The computed response iscompared to a measured response of the actual system to obtain an“observed” response, which is used for actual feedback decisions. Theobserved response is a favorable, tuned value that balances the smooth,continuous nature of the simulated response with the measured response,which can detect outside influences on the system.

In one aspect, the motor 482 may be controlled by the motor driver 492and can be employed by the firing system of the surgical instrument ortool. In various forms, the motor 482 may be a brushed DC driving motorhaving a maximum rotational speed of approximately 25,000 RPM. In otherarrangements, the motor 482 may include a brushless motor, a cordlessmotor, a synchronous motor, a stepper motor, or any other suitableelectric motor. The motor driver 492 may comprise an H-bridge drivercomprising field-effect transistors (FETs), for example. The motor 482can be powered by a power assembly releasably mounted to the handleassembly or tool housing for supplying control power to the surgicalinstrument or tool. The power assembly may comprise a battery which mayinclude a number of battery cells connected in series that can be usedas the power source to power the surgical instrument or tool. In certaincircumstances, the battery cells of the power assembly may bereplaceable and/or rechargeable battery cells. In at least one example,the battery cells can be lithium-ion batteries which can be couplable toand separable from the power assembly.

The motor driver 492 may be an A3941 available from AllegroMicrosystems, Inc. The A3941 492 is a full-bridge controller for usewith external N-channel power metal-oxide semiconductor field-effecttransistors (MOSFETs) specifically designed for inductive loads, such asbrush DC motors. The driver 492 comprises a unique charge pump regulatorthat provides full (>10 V) gate drive for battery voltages down to 7 Vand allows the A3941 to operate with a reduced gate drive, down to 5.5V. A bootstrap capacitor may be employed to provide the above batterysupply voltage required for N-channel MOSFETs. An internal charge pumpfor the high-side drive allows DC (100% duty cycle) operation. The fullbridge can be driven in fast or slow decay modes using diode orsynchronous rectification. In the slow decay mode, current recirculationcan be through the high-side or the low-side FETs. The power FETs areprotected from shoot-through by resistor-adjustable dead time.Integrated diagnostics provide indications of undervoltage,overtemperature, and power bridge faults and can be configured toprotect the power MOSFETs under most short circuit conditions. Othermotor drivers may be readily substituted for use in the tracking system480 comprising an absolute positioning system.

The tracking system 480 comprises a controlled motor drive circuitarrangement comprising a position sensor 472 according to one aspect ofthis disclosure. The position sensor 472 for an absolute positioningsystem provides a unique position signal corresponding to the locationof a displacement member. In one aspect, the displacement memberrepresents a longitudinally movable drive member comprising a rack ofdrive teeth for meshing engagement with a corresponding drive gear of agear reducer assembly. In other aspects, the displacement memberrepresents the firing member, which could be adapted and configured toinclude a rack of drive teeth. In yet another aspect, the displacementmember represents a longitudinal displacement member to open and close aclamp arm, which can be adapted and configured to include a rack ofdrive teeth. In other aspects, the displacement member represents aclamp arm closure member configured to close and to open a clamp arm ofa stapler, ultrasonic, or electrosurgical device, or combinations of theabove. Accordingly, as used herein, the term displacement member is usedgenerically to refer to any movable member of the surgical instrument ortool such as the drive member, the clamp arm, or any element that can bedisplaced. Accordingly, the absolute positioning system can, in effect,track the displacement of the clamp arm by tracking the lineardisplacement of the longitudinally movable drive member.

In other aspects, the absolute positioning system can be configured totrack the position of a clamp arm in the process of closing or opening.In various other aspects, the displacement member may be coupled to anyposition sensor 472 suitable for measuring linear displacement. Thus,the longitudinally movable drive member, or clamp arm, or combinationsthereof, may be coupled to any suitable linear displacement sensor.Linear displacement sensors may include contact or non-contactdisplacement sensors. Linear displacement sensors may comprise linearvariable differential transformers (LVDT), differential variablereluctance transducers (DVRT), a slide potentiometer, a magnetic sensingsystem comprising a movable magnet and a series of linearly arrangedHall effect sensors, a magnetic sensing system comprising a fixed magnetand a series of movable, linearly arranged Hall effect sensors, anoptical sensing system comprising a movable light source and a series oflinearly arranged photo diodes or photo detectors, an optical sensingsystem comprising a fixed light source and a series of movable linearly,arranged photo diodes or photo detectors, or any combination thereof.

The electric motor 482 can include a rotatable shaft that operablyinterfaces with a gear assembly that is mounted in meshing engagementwith a set, or rack, of drive teeth on the displacement member. A sensorelement may be operably coupled to a gear assembly such that a singlerevolution of the position sensor 472 element corresponds to some linearlongitudinal translation of the displacement member. An arrangement ofgearing and sensors can be connected to the linear actuator, via a rackand pinion arrangement, or a rotary actuator, via a spur gear or otherconnection. A power source supplies power to the absolute positioningsystem and an output indicator may display the output of the absolutepositioning system. The displacement member represents thelongitudinally movable drive member comprising a rack of drive teethformed thereon for meshing engagement with a corresponding drive gear ofthe gear reducer assembly. The displacement member represents thelongitudinally movable firing member to open and close a clamp arm.

A single revolution of the sensor element associated with the positionsensor 472 is equivalent to a longitudinal linear displacement d₁ of theof the displacement member, where d₁ is the longitudinal linear distancethat the displacement member moves from point “a” to point “b” after asingle revolution of the sensor element coupled to the displacementmember. The sensor arrangement may be connected via a gear reductionthat results in the position sensor 472 completing one or morerevolutions for the full stroke of the displacement member. The positionsensor 472 may complete multiple revolutions for the full stroke of thedisplacement member.

A series of switches, where n is an integer greater than one, may beemployed alone or in combination with a gear reduction to provide aunique position signal for more than one revolution of the positionsensor 472. The state of the switches are fed back to themicrocontroller 461 that applies logic to determine a unique positionsignal corresponding to the longitudinal linear displacement d₁+d₂+ . .. d_(n) of the displacement member. The output of the position sensor472 is provided to the microcontroller 461. The position sensor 472 ofthe sensor arrangement may comprise a magnetic sensor, an analog rotarysensor like a potentiometer, or an array of analog Hall-effect elements,which output a unique combination of position signals or values.

The position sensor 472 may comprise any number of magnetic sensingelements, such as, for example, magnetic sensors classified according towhether they measure the total magnetic field or the vector componentsof the magnetic field. The techniques used to produce both types ofmagnetic sensors encompass many aspects of physics and electronics. Thetechnologies used for magnetic field sensing include search coil,fluxgate, optically pumped, nuclear precession, SQUID, Hall-effect,anisotropic magnetoresistance, giant magnetoresistance, magnetic tunneljunctions, giant magnetoimpedance, magnetostrictive/piezoelectriccomposites, magnetodiode, magnetotransistor, fiber-optic, magneto-optic,and microelectromechanical systems-based magnetic sensors, among others.

In one aspect, the position sensor 472 for the tracking system 480comprising an absolute positioning system comprises a magnetic rotaryabsolute positioning system. The position sensor 472 may be implementedas an AS5055EQFT single-chip magnetic rotary position sensor availablefrom Austria Microsystems, AG. The position sensor 472 is interfacedwith the microcontroller 461 to provide an absolute positioning system.The position sensor 472 is a low-voltage and low-power component andincludes four Hall-effect elements in an area of the position sensor 472that is located above a magnet. A high-resolution ADC and a smart powermanagement controller are also provided on the chip. A coordinaterotation digital computer (CORDIC) processor, also known as thedigit-by-digit method and Volder's algorithm, is provided to implement asimple and efficient algorithm to calculate hyperbolic and trigonometricfunctions that require only addition, subtraction, bitshift, and tablelookup operations. The angle position, alarm bits, and magnetic fieldinformation are transmitted over a standard serial communicationinterface, such as a serial peripheral interface (SPI) interface, to themicrocontroller 461. The position sensor 472 provides 12 or 14 bits ofresolution. The position sensor 472 may be an AS5055 chip provided in asmall QFN 16-pin 4×4×0.85 mm package.

The tracking system 480 comprising an absolute positioning system maycomprise and/or be programmed to implement a feedback controller, suchas a PID, state feedback, and adaptive controller. A power sourceconverts the signal from the feedback controller into a physical inputto the system: in this case the voltage. Other examples include a PWM ofthe voltage, current, and force. Other sensor(s) may be provided tomeasure physical parameters of the physical system in addition to theposition measured by the position sensor 472. In some aspects, the othersensor(s) can include sensor arrangements such as those described inU.S. Pat. No. 9,345,481, titled STAPLE CARTRIDGE TISSUE THICKNESS SENSORSYSTEM, which issued on May 24, 2016, which is herein incorporated byreference in its entirety; U.S. Patent Application Publication No.2014/0263552, titled STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM,which published on Sep. 18, 2014, which is herein incorporated byreference in its entirety; and U.S. patent application Ser. No.15/628,175, titled TECHNIQUES FOR ADAPTIVE CONTROL OF MOTOR VELOCITY OFA SURGICAL STAPLING AND CUTTING INSTRUMENT, filed Jun. 20, 2017, whichis herein incorporated by reference in its entirety. In a digital signalprocessing system, an absolute positioning system is coupled to adigital data acquisition system where the output of the absolutepositioning system will have a finite resolution and sampling frequency.The absolute positioning system may comprise a compare-and-combinecircuit to combine a computed response with a measured response usingalgorithms, such as a weighted average and a theoretical control loop,that drive the computed response towards the measured response. Thecomputed response of the physical system takes into account propertieslike mass, inertia, viscous friction, inductance resistance, etc., topredict what the states and outputs of the physical system will be byknowing the input.

The absolute positioning system provides an absolute position of thedisplacement member upon power-up of the instrument, without retractingor advancing the displacement member to a reset (zero or home) positionas may be required with conventional rotary encoders that merely countthe number of steps forwards or backwards that the motor 482 has takento infer the position of a device actuator, drive bar, knife, or thelike.

A sensor 474, such as, for example, a strain gauge or a micro-straingauge, is configured to measure one or more parameters of the endeffector, such as, for example, the amplitude of the strain exerted onthe anvil during a clamping operation, which can be indicative of theclosure forces applied to the anvil. The measured strain is converted toa digital signal and provided to the processor 462. Alternatively, or inaddition to the sensor 474, a sensor 476, such as, for example, a loadsensor, can measure the closure force applied by the closure drivesystem to the anvil in a stapler or a clamp arm in an ultrasonic orelectrosurgical instrument. The sensor 476, such as, for example, a loadsensor, can measure the firing force applied to a closure member coupledto a clamp arm of the surgical instrument or tool or the force appliedby a clamp arm to tissue located in the jaws of an ultrasonic orelectrosurgical instrument. Alternatively, a current sensor 478 can beemployed to measure the current drawn by the motor 482. The displacementmember also may be configured to engage a clamp arm to open or close theclamp arm. The force sensor may be configured to measure the clampingforce on tissue. The force required to advance the displacement membercan correspond to the current drawn by the motor 482, for example. Themeasured force is converted to a digital signal and provided to theprocessor 462.

In one form, the strain gauge sensor 474 can be used to measure theforce applied to the tissue by the end effector. A strain gauge can becoupled to the end effector to measure the force on the tissue beingtreated by the end effector. A system for measuring forces applied tothe tissue grasped by the end effector comprises a strain gauge sensor474, such as, for example, a micro-strain gauge, that is configured tomeasure one or more parameters of the end effector, for example. In oneaspect, the strain gauge sensor 474 can measure the amplitude ormagnitude of the strain exerted on a jaw member of an end effectorduring a clamping operation, which can be indicative of the tissuecompression. The measured strain is converted to a digital signal andprovided to a processor 462 of the microcontroller 461. A load sensor476 can measure the force used to operate the knife element, forexample, to cut the tissue captured between the anvil and the staplecartridge. A load sensor 476 can measure the force used to operate theclamp arm element, for example, to capture tissue between the clamp armand an ultrasonic blade or to capture tissue between the clamp arm and ajaw of an electrosurgical instrument. A magnetic field sensor can beemployed to measure the thickness of the captured tissue. Themeasurement of the magnetic field sensor also may be converted to adigital signal and provided to the processor 462.

The measurements of the tissue compression, the tissue thickness, and/orthe force required to close the end effector on the tissue, asrespectively measured by the sensors 474, 476, can be used by themicrocontroller 461 to characterize the selected position of the firingmember and/or the corresponding value of the speed of the firing member.In one instance, a memory 468 may store a technique, an equation, and/ora lookup table which can be employed by the microcontroller 461 in theassessment.

The control system 470 of the surgical instrument or tool also maycomprise wired or wireless communication circuits to communicate withthe modular communication hub as shown in FIGS. 8-11.

FIG. 11 illustrates a control circuit 500 configured to control aspectsof the surgical instrument or tool according to one aspect of thisdisclosure. The control circuit 500 can be configured to implementvarious processes described herein. The control circuit 500 may comprisea microcontroller comprising one or more processors 502 (e.g.,microprocessor, microcontroller) coupled to at least one memory circuit504. The memory circuit 504 stores machine-executable instructions that,when executed by the processor 502, cause the processor 502 to executemachine instructions to implement various processes described herein.The processor 502 may be any one of a number of single-core or multicoreprocessors known in the art. The memory circuit 504 may comprisevolatile and non-volatile storage media. The processor 502 may includean instruction processing unit 506 and an arithmetic unit 508. Theinstruction processing unit may be configured to receive instructionsfrom the memory circuit 504 of this disclosure.

FIG. 12 illustrates a combinational logic circuit 510 configured tocontrol aspects of the surgical instrument or tool according to oneaspect of this disclosure. The combinational logic circuit 510 can beconfigured to implement various processes described herein. Thecombinational logic circuit 510 may comprise a finite state machinecomprising a combinational logic 512 configured to receive dataassociated with the surgical instrument or tool at an input 514, processthe data by the combinational logic 512, and provide an output 516.

FIG. 13 illustrates a sequential logic circuit 520 configured to controlaspects of the surgical instrument or tool according to one aspect ofthis disclosure. The sequential logic circuit 520 or the combinationallogic 522 can be configured to implement various processes describedherein. The sequential logic circuit 520 may comprise a finite statemachine. The sequential logic circuit 520 may comprise a combinationallogic 522, at least one memory circuit 524, and a clock 529, forexample. The at least one memory circuit 524 can store a current stateof the finite state machine. In certain instances, the sequential logiccircuit 520 may be synchronous or asynchronous. The combinational logic522 is configured to receive data associated with the surgicalinstrument or tool from an input 526, process the data by thecombinational logic 522, and provide an output 528. In other aspects,the circuit may comprise a combination of a processor (e.g., processor502, FIG. 11) and a finite state machine to implement various processesherein. In other aspects, the finite state machine may comprise acombination of a combinational logic circuit (e.g., combinational logiccircuit 510, FIG. 12) and the sequential logic circuit 520.

FIG. 14 illustrates a surgical instrument or tool comprising a pluralityof motors which can be activated to perform various functions. Incertain instances, a first motor can be activated to perform a firstfunction, a second motor can be activated to perform a second function,a third motor can be activated to perform a third function, a fourthmotor can be activated to perform a fourth function, and so on. Incertain instances, the plurality of motors of robotic surgicalinstrument 600 can be individually activated to cause firing, closure,and/or articulation motions in the end effector. The firing, closure,and/or articulation motions can be transmitted to the end effectorthrough a shaft assembly, for example.

In certain instances, the surgical instrument system or tool may includea firing motor 602. The firing motor 602 may be operably coupled to afiring motor drive assembly 604 which can be configured to transmitfiring motions, generated by the motor 602 to the end effector, inparticular to displace the clamp arm closure member. The closure membermay be retracted by reversing the direction of the motor 602, which alsocauses the clamp arm to open.

In certain instances, the surgical instrument or tool may include aclosure motor 603. The closure motor 603 may be operably coupled to aclosure motor drive assembly 605 which can be configured to transmitclosure motions, generated by the motor 603 to the end effector, inparticular to displace a closure tube to close the anvil and compresstissue between the anvil and the staple cartridge. The closure motor 603may be operably coupled to a closure motor drive assembly 605 which canbe configured to transmit closure motions, generated by the motor 603 tothe end effector, in particular to displace a closure tube to close theclamp arm and compress tissue between the clamp arm and either anultrasonic blade or jaw member of an electrosurgical device. The closuremotions may cause the end effector to transition from an openconfiguration to an approximated configuration to capture tissue, forexample. The end effector may be transitioned to an open position byreversing the direction of the motor 603.

In certain instances, the surgical instrument or tool may include one ormore articulation motors 606 a, 606 b, for example. The motors 606 a,606 b may be operably coupled to respective articulation motor driveassemblies 608 a, 608 b, which can be configured to transmitarticulation motions generated by the motors 606 a, 606 b to the endeffector. In certain instances, the articulation motions may cause theend effector to articulate relative to the shaft, for example.

As described above, the surgical instrument or tool may include aplurality of motors which may be configured to perform variousindependent functions. In certain instances, the plurality of motors ofthe surgical instrument or tool can be individually or separatelyactivated to perform one or more functions while the other motors remaininactive. For example, the articulation motors 606 a, 606 b can beactivated to cause the end effector to be articulated while the firingmotor 602 remains inactive. Alternatively, the firing motor 602 can beactivated to fire the plurality of staples, and/or to advance thecutting edge, while the articulation motor 606 remains inactive.Furthermore, the closure motor 603 may be activated simultaneously withthe firing motor 602 to cause the closure tube or closure member toadvance distally as described in more detail hereinbelow.

In certain instances, the surgical instrument or tool may include acommon control module 610 which can be employed with a plurality ofmotors of the surgical instrument or tool. In certain instances, thecommon control module 610 may accommodate one of the plurality of motorsat a time. For example, the common control module 610 can be couplableto and separable from the plurality of motors of the robotic surgicalinstrument individually. In certain instances, a plurality of the motorsof the surgical instrument or tool may share one or more common controlmodules such as the common control module 610. In certain instances, aplurality of motors of the surgical instrument or tool can beindividually and selectively engaged with the common control module 610.In certain instances, the common control module 610 can be selectivelyswitched from interfacing with one of a plurality of motors of thesurgical instrument or tool to interfacing with another one of theplurality of motors of the surgical instrument or tool.

In at least one example, the common control module 610 can beselectively switched between operable engagement with the articulationmotors 606 a, 606 b and operable engagement with either the firing motor602 or the closure motor 603. In at least one example, as illustrated inFIG. 14, a switch 614 can be moved or transitioned between a pluralityof positions and/or states. In a first position 616, the switch 614 mayelectrically couple the common control module 610 to the firing motor602; in a second position 617, the switch 614 may electrically couplethe common control module 610 to the closure motor 603; in a thirdposition 618 a, the switch 614 may electrically couple the commoncontrol module 610 to the first articulation motor 606 a; and in afourth position 618 b, the switch 614 may electrically couple the commoncontrol module 610 to the second articulation motor 606 b, for example.In certain instances, separate common control modules 610 can beelectrically coupled to the firing motor 602, the closure motor 603, andthe articulations motor 606 a, 606 b at the same time. In certaininstances, the switch 614 may be a mechanical switch, anelectromechanical switch, a solid-state switch, or any suitableswitching mechanism.

Each of the motors 602, 603, 606 a, 606 b may comprise a torque sensorto measure the output torque on the shaft of the motor. The force on anend effector may be sensed in any conventional manner, such as by forcesensors on the outer sides of the jaws or by a torque sensor for themotor actuating the jaws.

In various instances, as illustrated in FIG. 14, the common controlmodule 610 may comprise a motor driver 626 which may comprise one ormore H-Bridge FETs. The motor driver 626 may modulate the powertransmitted from a power source 628 to a motor coupled to the commoncontrol module 610 based on input from a microcontroller 620 (the“controller”), for example. In certain instances, the microcontroller620 can be employed to determine the current drawn by the motor, forexample, while the motor is coupled to the common control module 610, asdescribed above.

In certain instances, the microcontroller 620 may include amicroprocessor 622 (the “processor”) and one or more non-transitorycomputer-readable mediums or memory units 624 (the “memory”). In certaininstances, the memory 624 may store various program instructions, whichwhen executed may cause the processor 622 to perform a plurality offunctions and/or calculations described herein. In certain instances,one or more of the memory units 624 may be coupled to the processor 622,for example. In various aspects, the microcontroller 620 may communicateover a wired or wireless channel, or combinations thereof.

In certain instances, the power source 628 can be employed to supplypower to the microcontroller 620, for example. In certain instances, thepower source 628 may comprise a battery (or “battery pack” or “powerpack”), such as a lithium-ion battery, for example. In certaininstances, the battery pack may be configured to be releasably mountedto a handle for supplying power to the surgical instrument 600. A numberof battery cells connected in series may be used as the power source628. In certain instances, the power source 628 may be replaceableand/or rechargeable, for example.

In various instances, the processor 622 may control the motor driver 626to control the position, direction of rotation, and/or velocity of amotor that is coupled to the common control module 610. In certaininstances, the processor 622 can signal the motor driver 626 to stopand/or disable a motor that is coupled to the common control module 610.It should be understood that the term “processor” as used hereinincludes any suitable microprocessor, microcontroller, or other basiccomputing device that incorporates the functions of a computer's centralprocessing unit (CPU) on an integrated circuit or, at most, a fewintegrated circuits. The processor 622 is a multipurpose, programmabledevice that accepts digital data as input, processes it according toinstructions stored in its memory, and provides results as output. It isan example of sequential digital logic, as it has internal memory.Processors operate on numbers and symbols represented in the binarynumeral system.

In one instance, the processor 622 may be any single-core or multicoreprocessor such as those known under the trade name ARM Cortex by TexasInstruments. In certain instances, the microcontroller 620 may be an LM4F230H5QR, available from Texas Instruments, for example. In at leastone example, the Texas Instruments LM4F230H5QR is an ARM Cortex-M4FProcessor Core comprising an on-chip memory of 256 KB single-cycle flashmemory, or other non-volatile memory, up to 40 MHz, a prefetch buffer toimprove performance above 40 MHz, a 32 KB single-cycle SRAM, an internalROM loaded with StellarisWare® software, a 2 KB EEPROM, one or more PWMmodules, one or more QEI analogs, one or more 12-bit ADCs with 12 analoginput channels, among other features that are readily available for theproduct datasheet. Other microcontrollers may be readily substituted foruse with the module 4410. Accordingly, the present disclosure should notbe limited in this context.

In certain instances, the memory 624 may include program instructionsfor controlling each of the motors of the surgical instrument 600 thatare couplable to the common control module 610. For example, the memory624 may include program instructions for controlling the firing motor602, the closure motor 603, and the articulation motors 606 a, 606 b.Such program instructions may cause the processor 622 to control thefiring, closure, and articulation functions in accordance with inputsfrom algorithms or control programs of the surgical instrument or tool.

In certain instances, one or more mechanisms and/or sensors such as, forexample, sensors 630 can be employed to alert the processor 622 to theprogram instructions that should be used in a particular setting. Forexample, the sensors 630 may alert the processor 622 to use the programinstructions associated with firing, closing, and articulating the endeffector. In certain instances, the sensors 630 may comprise positionsensors which can be employed to sense the position of the switch 614,for example. Accordingly, the processor 622 may use the programinstructions associated with firing the closure member coupled to theclamp arm of the end effector upon detecting, through the sensors 630for example, that the switch 614 is in the first position 616; theprocessor 622 may use the program instructions associated with closingthe anvil upon detecting, through the sensors 630 for example, that theswitch 614 is in the second position 617; and the processor 622 may usethe program instructions associated with articulating the end effectorupon detecting, through the sensors 630 for example, that the switch 614is in the third or fourth position 618 a, 618 b.

FIG. 15 is a schematic diagram of a robotic surgical instrument 700configured to operate a surgical tool described herein according to oneaspect of this disclosure. The robotic surgical instrument 700 may beprogrammed or configured to control distal/proximal translation of adisplacement member, distal/proximal displacement of a closure tube,shaft rotation, and articulation, either with single or multiplearticulation drive links. In one aspect, the surgical instrument 700 maybe programmed or configured to individually control a firing member, aclosure member, a shaft member, or one or more articulation members, orcombinations thereof. The surgical instrument 700 comprises a controlcircuit 710 configured to control motor-driven firing members, closuremembers, shaft members, or one or more articulation members, orcombinations thereof.

In one aspect, the robotic surgical instrument 700 comprises a controlcircuit 710 configured to control a clamp arm 716 and a closure member714 portion of an end effector 702, an ultrasonic blade 718 coupled toan ultrasonic transducer 719 excited by an ultrasonic generator 721, ashaft 740, and one or more articulation members 742 a, 742 b via aplurality of motors 704 a-704 e. A position sensor 734 may be configuredto provide position feedback of the closure member 714 to the controlcircuit 710. Other sensors 738 may be configured to provide feedback tothe control circuit 710. A timer/counter 731 provides timing andcounting information to the control circuit 710. An energy source 712may be provided to operate the motors 704 a-704 e, and a current sensor736 provides motor current feedback to the control circuit 710. Themotors 704 a-704 e can be operated individually by the control circuit710 in an open-loop or closed-loop feedback control.

In one aspect, the control circuit 710 may comprise one or moremicrocontrollers, microprocessors, or other suitable processors forexecuting instructions that cause the processor or processors to performone or more tasks. In one aspect, a timer/counter 731 provides an outputsignal, such as the elapsed time or a digital count, to the controlcircuit 710 to correlate the position of the closure member 714 asdetermined by the position sensor 734 with the output of thetimer/counter 731 such that the control circuit 710 can determine theposition of the closure member 714 at a specific time (t) relative to astarting position or the time (t) when the closure member 714 is at aspecific position relative to a starting position. The timer/counter 731may be configured to measure elapsed time, count external events, ortime external events.

In one aspect, the control circuit 710 may be programmed to controlfunctions of the end effector 702 based on one or more tissueconditions. The control circuit 710 may be programmed to sense tissueconditions, such as thickness, either directly or indirectly, asdescribed herein. The control circuit 710 may be programmed to select afiring control program or closure control program based on tissueconditions. A firing control program may describe the distal motion ofthe displacement member. Different firing control programs may beselected to better treat different tissue conditions. For example, whenthicker tissue is present, the control circuit 710 may be programmed totranslate the displacement member at a lower velocity and/or with lowerpower. When thinner tissue is present, the control circuit 710 may beprogrammed to translate the displacement member at a higher velocityand/or with higher power. A closure control program may control theclosure force applied to the tissue by the clamp arm 716. Other controlprograms control the rotation of the shaft 740 and the articulationmembers 742 a, 742 b.

In one aspect, the control circuit 710 may generate motor set pointsignals. The motor set point signals may be provided to various motorcontrollers 708 a-708 e. The motor controllers 708 a-708 e may compriseone or more circuits configured to provide motor drive signals to themotors 704 a-704 e to drive the motors 704 a-704 e as described herein.In some examples, the motors 704 a-704 e may be brushed DC electricmotors. For example, the velocity of the motors 704 a-704 e may beproportional to the respective motor drive signals. In some examples,the motors 704 a-704 e may be brushless DC electric motors, and therespective motor drive signals may comprise a PWM signal provided to oneor more stator windings of the motors 704 a-704 e. Also, in someexamples, the motor controllers 708 a-708 e may be omitted and thecontrol circuit 710 may generate the motor drive signals directly.

In one aspect, the control circuit 710 may initially operate each of themotors 704 a-704 e in an open-loop configuration for a first open-loopportion of a stroke of the displacement member. Based on the response ofthe robotic surgical instrument 700 during the open-loop portion of thestroke, the control circuit 710 may select a firing control program in aclosed-loop configuration. The response of the instrument may include atranslation distance of the displacement member during the open-loopportion, a time elapsed during the open-loop portion, the energyprovided to one of the motors 704 a-704 e during the open-loop portion,a sum of pulse widths of a motor drive signal, etc. After the open-loopportion, the control circuit 710 may implement the selected firingcontrol program for a second portion of the displacement member stroke.For example, during a closed-loop portion of the stroke, the controlcircuit 710 may modulate one of the motors 704 a-704 e based ontranslation data describing a position of the displacement member in aclosed-loop manner to translate the displacement member at a constantvelocity.

In one aspect, the motors 704 a-704 e may receive power from an energysource 712. The energy source 712 may be a DC power supply driven by amain alternating current power source, a battery, a super capacitor, orany other suitable energy source. The motors 704 a-704 e may bemechanically coupled to individual movable mechanical elements such asthe closure member 714, clamp arm 716, shaft 740, articulation 742 a,and articulation 742 b via respective transmissions 706 a-706 e. Thetransmissions 706 a-706 e may include one or more gears or other linkagecomponents to couple the motors 704 a-704 e to movable mechanicalelements. A position sensor 734 may sense a position of the closuremember 714. The position sensor 734 may be or include any type of sensorthat is capable of generating position data that indicate a position ofthe closure member 714. In some examples, the position sensor 734 mayinclude an encoder configured to provide a series of pulses to thecontrol circuit 710 as the closure member 714 translates distally andproximally. The control circuit 710 may track the pulses to determinethe position of the closure member 714. Other suitable position sensorsmay be used, including, for example, a proximity sensor. Other types ofposition sensors may provide other signals indicating motion of theclosure member 714. Also, in some examples, the position sensor 734 maybe omitted. Where any of the motors 704 a-704 e is a stepper motor, thecontrol circuit 710 may track the position of the closure member 714 byaggregating the number and direction of steps that the motor 704 hasbeen instructed to execute. The position sensor 734 may be located inthe end effector 702 or at any other portion of the instrument. Theoutputs of each of the motors 704 a-704 e include a torque sensor 744a-744 e to sense force and have an encoder to sense rotation of thedrive shaft.

In one aspect, the control circuit 710 is configured to drive a firingmember such as the closure member 714 portion of the end effector 702.The control circuit 710 provides a motor set point to a motor control708 a, which provides a drive signal to the motor 704 a. The outputshaft of the motor 704 a is coupled to a torque sensor 744 a. The torquesensor 744 a is coupled to a transmission 706 a which is coupled to theclosure member 714. The transmission 706 a comprises movable mechanicalelements such as rotating elements and a firing member to control themovement of the closure member 714 distally and proximally along alongitudinal axis of the end effector 702. In one aspect, the motor 704a may be coupled to the knife gear assembly, which includes a knife gearreduction set that includes a first knife drive gear and a second knifedrive gear. A torque sensor 744 a provides a firing force feedbacksignal to the control circuit 710. The firing force signal representsthe force required to fire or displace the closure member 714. Aposition sensor 734 may be configured to provide the position of theclosure member 714 along the firing stroke or the position of the firingmember as a feedback signal to the control circuit 710. The end effector702 may include additional sensors 738 configured to provide feedbacksignals to the control circuit 710. When ready to use, the controlcircuit 710 may provide a firing signal to the motor control 708 a. Inresponse to the firing signal, the motor 704 a may drive the firingmember distally along the longitudinal axis of the end effector 702 froma proximal stroke start position to a stroke end position distal to thestroke start position. As the closure member 714 translates distally,the clamp arm 716 closes towards the ultrasonic blade 718.

In one aspect, the control circuit 710 is configured to drive a closuremember such as the clamp arm 716 portion of the end effector 702. Thecontrol circuit 710 provides a motor set point to a motor control 708 b,which provides a drive signal to the motor 704 b. The output shaft ofthe motor 704 b is coupled to a torque sensor 744 b. The torque sensor744 b is coupled to a transmission 706 b which is coupled to the clamparm 716. The transmission 706 b comprises movable mechanical elementssuch as rotating elements and a closure member to control the movementof the clamp arm 716 from the open and closed positions. In one aspect,the motor 704 b is coupled to a closure gear assembly, which includes aclosure reduction gear set that is supported in meshing engagement withthe closure spur gear. The torque sensor 744 b provides a closure forcefeedback signal to the control circuit 710. The closure force feedbacksignal represents the closure force applied to the clamp arm 716. Theposition sensor 734 may be configured to provide the position of theclosure member as a feedback signal to the control circuit 710.Additional sensors 738 in the end effector 702 may provide the closureforce feedback signal to the control circuit 710. The pivotable clamparm 716 is positioned opposite the ultrasonic blade 718. When ready touse, the control circuit 710 may provide a closure signal to the motorcontrol 708 b. In response to the closure signal, the motor 704 badvances a closure member to grasp tissue between the clamp arm 716 andthe ultrasonic blade 718.

In one aspect, the control circuit 710 is configured to rotate a shaftmember such as the shaft 740 to rotate the end effector 702. The controlcircuit 710 provides a motor set point to a motor control 708 c, whichprovides a drive signal to the motor 704 c. The output shaft of themotor 704 c is coupled to a torque sensor 744 c. The torque sensor 744 cis coupled to a transmission 706 c which is coupled to the shaft 740.The transmission 706 c comprises movable mechanical elements such asrotating elements to control the rotation of the shaft 740 clockwise orcounterclockwise up to and over 360°. In one aspect, the motor 704 c iscoupled to the rotational transmission assembly, which includes a tubegear segment that is formed on (or attached to) the proximal end of theproximal closure tube for operable engagement by a rotational gearassembly that is operably supported on the tool mounting plate. Thetorque sensor 744 c provides a rotation force feedback signal to thecontrol circuit 710. The rotation force feedback signal represents therotation force applied to the shaft 740. The position sensor 734 may beconfigured to provide the position of the closure member as a feedbacksignal to the control circuit 710. Additional sensors 738 such as ashaft encoder may provide the rotational position of the shaft 740 tothe control circuit 710.

In one aspect, the control circuit 710 is configured to articulate theend effector 702. The control circuit 710 provides a motor set point toa motor control 708 d, which provides a drive signal to the motor 704 d.The output shaft of the motor 704 d is coupled to a torque sensor 744 d.The torque sensor 744 d is coupled to a transmission 706 d which iscoupled to an articulation member 742 a. The transmission 706 dcomprises movable mechanical elements such as articulation elements tocontrol the articulation of the end effector 702 ±65°. In one aspect,the motor 704 d is coupled to an articulation nut, which is rotatablyjournaled on the proximal end portion of the distal spine portion and isrotatably driven thereon by an articulation gear assembly. The torquesensor 744 d provides an articulation force feedback signal to thecontrol circuit 710. The articulation force feedback signal representsthe articulation force applied to the end effector 702. Sensors 738,such as an articulation encoder, may provide the articulation positionof the end effector 702 to the control circuit 710.

In another aspect, the articulation function of the robotic surgicalsystem 700 may comprise two articulation members, or links, 742 a, 742b. These articulation members 742 a, 742 b are driven by separate diskson the robot interface (the rack) which are driven by the two motors 708d, 708 e. When the separate firing motor 704 a is provided, each ofarticulation links 742 a, 742 b can be antagonistically driven withrespect to the other link in order to provide a resistive holding motionand a load to the head when it is not moving and to provide anarticulation motion as the head is articulated. The articulation members742 a, 742 b attach to the head at a fixed radius as the head isrotated. Accordingly, the mechanical advantage of the push-and-pull linkchanges as the head is rotated. This change in the mechanical advantagemay be more pronounced with other articulation link drive systems.

In one aspect, the one or more motors 704 a-704 e may comprise a brushedDC motor with a gearbox and mechanical links to a firing member, closuremember, or articulation member. Another example includes electric motors704 a-704 e that operate the movable mechanical elements such as thedisplacement member, articulation links, closure tube, and shaft. Anoutside influence is an unmeasured, unpredictable influence of thingslike tissue, surrounding bodies, and friction on the physical system.Such outside influence can be referred to as drag, which acts inopposition to one of electric motors 704 a-704 e. The outside influence,such as drag, may cause the operation of the physical system to deviatefrom a desired operation of the physical system.

In one aspect, the position sensor 734 may be implemented as an absolutepositioning system. In one aspect, the position sensor 734 may comprisea magnetic rotary absolute positioning system implemented as anAS5055EQFT single-chip magnetic rotary position sensor available fromAustria Microsystems, AG. The position sensor 734 may interface with thecontrol circuit 710 to provide an absolute positioning system. Theposition may include multiple Hall-effect elements located above amagnet and coupled to a CORDIC processor, also known as thedigit-by-digit method and Volder's algorithm, that is provided toimplement a simple and efficient algorithm to calculate hyperbolic andtrigonometric functions that require only addition, subtraction,bitshift, and table lookup operations.

In one aspect, the control circuit 710 may be in communication with oneor more sensors 738. The sensors 738 may be positioned on the endeffector 702 and adapted to operate with the robotic surgical instrument700 to measure the various derived parameters such as the gap distanceversus time, tissue compression versus time, and anvil strain versustime. The sensors 738 may comprise a magnetic sensor, a magnetic fieldsensor, a strain gauge, a load cell, a pressure sensor, a force sensor,a torque sensor, an inductive sensor such as an eddy current sensor, aresistive sensor, a capacitive sensor, an optical sensor, and/or anyother suitable sensor for measuring one or more parameters of the endeffector 702. The sensors 738 may include one or more sensors. Thesensors 738 may be located on the clamp arm 716 to determine tissuelocation using segmented electrodes. The torque sensors 744 a-744 e maybe configured to sense force such as firing force, closure force, and/orarticulation force, among others. Accordingly, the control circuit 710can sense (1) the closure load experienced by the distal closure tubeand its position, (2) the firing member at the rack and its position,(3) what portion of the ultrasonic blade 718 has tissue on it, and (4)the load and position on both articulation rods.

In one aspect, the one or more sensors 738 may comprise a strain gauge,such as a micro-strain gauge, configured to measure the magnitude of thestrain in the clamp arm 716 during a clamped condition. The strain gaugeprovides an electrical signal whose amplitude varies with the magnitudeof the strain. The sensors 738 may comprise a pressure sensor configuredto detect a pressure generated by the presence of compressed tissuebetween the clamp arm 716 and the ultrasonic blade 718. The sensors 738may be configured to detect impedance of a tissue section locatedbetween the clamp arm 716 and the ultrasonic blade 718 that isindicative of the thickness and/or fullness of tissue locatedtherebetween.

In one aspect, the sensors 738 may be implemented as one or more limitswitches, electromechanical devices, solid-state switches, Hall-effectdevices, magneto-resistive (MR) devices, giant magneto-resistive (GMR)devices, magnetometers, among others. In other implementations, thesensors 738 may be implemented as solid-state switches that operateunder the influence of light, such as optical sensors, IR sensors,ultraviolet sensors, among others. Still, the switches may besolid-state devices such as transistors (e.g., FET, junction FET,MOSFET, bipolar, and the like). In other implementations, the sensors738 may include electrical conductorless switches, ultrasonic switches,accelerometers, and inertial sensors, among others.

In one aspect, the sensors 738 may be configured to measure forcesexerted on the clamp arm 716 by the closure drive system. For example,one or more sensors 738 can be at an interaction point between theclosure tube and the clamp arm 716 to detect the closure forces appliedby the closure tube to the clamp arm 716. The forces exerted on theclamp arm 716 can be representative of the tissue compressionexperienced by the tissue section captured between the clamp arm 716 andthe ultrasonic blade 718. The one or more sensors 738 can be positionedat various interaction points along the closure drive system to detectthe closure forces applied to the clamp arm 716 by the closure drivesystem. The one or more sensors 738 may be sampled in real time during aclamping operation by the processor of the control circuit 710. Thecontrol circuit 710 receives real-time sample measurements to provideand analyze time-based information and assess, in real time, closureforces applied to the clamp arm 716.

In one aspect, a current sensor 736 can be employed to measure thecurrent drawn by each of the motors 704 a-704 e. The force required toadvance any of the movable mechanical elements such as the closuremember 714 corresponds to the current drawn by one of the motors 704a-704 e. The force is converted to a digital signal and provided to thecontrol circuit 710. The control circuit 710 can be configured tosimulate the response of the actual system of the instrument in thesoftware of the controller. A displacement member can be actuated tomove the closure member 714 in the end effector 702 at or near a targetvelocity. The robotic surgical instrument 700 can include a feedbackcontroller, which can be one of any feedback controllers, including, butnot limited to a PID, a state feedback, a linear-quadratic (LQR), and/oran adaptive controller, for example. The robotic surgical instrument 700can include a power source to convert the signal from the feedbackcontroller into a physical input such as case voltage, PWM voltage,frequency modulated voltage, current, torque, and/or force, for example.Additional details are disclosed in U.S. patent application Ser. No.15/636,829, titled CLOSED LOOP VELOCITY CONTROL TECHNIQUES FOR ROBOTICSURGICAL INSTRUMENT, filed Jun. 29, 2017, which is herein incorporatedby reference in its entirety.

FIG. 16 illustrates a schematic diagram of a surgical instrument 750configured to control the distal translation of a displacement memberaccording to one aspect of this disclosure. In one aspect, the surgicalinstrument 750 is programmed to control the distal translation of adisplacement member such as the closure member 764. The surgicalinstrument 750 comprises an end effector 752 that may comprise a clamparm 766, a closure member 764, and an ultrasonic blade 768 coupled to anultrasonic transducer 769 driven by an ultrasonic generator 771.

The position, movement, displacement, and/or translation of a lineardisplacement member, such as the closure member 764, can be measured byan absolute positioning system, sensor arrangement, and position sensor784. Because the closure member 764 is coupled to a longitudinallymovable drive member, the position of the closure member 764 can bedetermined by measuring the position of the longitudinally movable drivemember employing the position sensor 784. Accordingly, in the followingdescription, the position, displacement, and/or translation of theclosure member 764 can be achieved by the position sensor 784 asdescribed herein. A control circuit 760 may be programmed to control thetranslation of the displacement member, such as the closure member 764.The control circuit 760, in some examples, may comprise one or moremicrocontrollers, microprocessors, or other suitable processors forexecuting instructions that cause the processor or processors to controlthe displacement member, e.g., the closure member 764, in the mannerdescribed. In one aspect, a timer/counter 781 provides an output signal,such as the elapsed time or a digital count, to the control circuit 760to correlate the position of the closure member 764 as determined by theposition sensor 784 with the output of the timer/counter 781 such thatthe control circuit 760 can determine the position of the closure member764 at a specific time (t) relative to a starting position. Thetimer/counter 781 may be configured to measure elapsed time, countexternal events, or time external events.

The control circuit 760 may generate a motor set point signal 772. Themotor set point signal 772 may be provided to a motor controller 758.The motor controller 758 may comprise one or more circuits configured toprovide a motor drive signal 774 to the motor 754 to drive the motor 754as described herein. In some examples, the motor 754 may be a brushed DCelectric motor. For example, the velocity of the motor 754 may beproportional to the motor drive signal 774. In some examples, the motor754 may be a brushless DC electric motor and the motor drive signal 774may comprise a PWM signal provided to one or more stator windings of themotor 754. Also, in some examples, the motor controller 758 may beomitted, and the control circuit 760 may generate the motor drive signal774 directly.

The motor 754 may receive power from an energy source 762. The energysource 762 may be or include a battery, a super capacitor, or any othersuitable energy source. The motor 754 may be mechanically coupled to theclosure member 764 via a transmission 756. The transmission 756 mayinclude one or more gears or other linkage components to couple themotor 754 to the closure member 764. A position sensor 784 may sense aposition of the closure member 764. The position sensor 784 may be orinclude any type of sensor that is capable of generating position datathat indicate a position of the closure member 764. In some examples,the position sensor 784 may include an encoder configured to provide aseries of pulses to the control circuit 760 as the closure member 764translates distally and proximally. The control circuit 760 may trackthe pulses to determine the position of the closure member 764. Othersuitable position sensors may be used, including, for example, aproximity sensor. Other types of position sensors may provide othersignals indicating motion of the closure member 764. Also, in someexamples, the position sensor 784 may be omitted. Where the motor 754 isa stepper motor, the control circuit 760 may track the position of theclosure member 764 by aggregating the number and direction of steps thatthe motor 754 has been instructed to execute. The position sensor 784may be located in the end effector 752 or at any other portion of theinstrument.

The control circuit 760 may be in communication with one or more sensors788. The sensors 788 may be positioned on the end effector 752 andadapted to operate with the surgical instrument 750 to measure thevarious derived parameters such as gap distance versus time, tissuecompression versus time, and anvil strain versus time. The sensors 788may comprise a magnetic sensor, a magnetic field sensor, a strain gauge,a pressure sensor, a force sensor, an inductive sensor such as an eddycurrent sensor, a resistive sensor, a capacitive sensor, an opticalsensor, and/or any other suitable sensor for measuring one or moreparameters of the end effector 752. The sensors 788 may include one ormore sensors.

The one or more sensors 788 may comprise a strain gauge, such as amicro-strain gauge, configured to measure the magnitude of the strain inthe clamp arm 766 during a clamped condition. The strain gauge providesan electrical signal whose amplitude varies with the magnitude of thestrain. The sensors 788 may comprise a pressure sensor configured todetect a pressure generated by the presence of compressed tissue betweenthe clamp arm 766 and the ultrasonic blade 768. The sensors 788 may beconfigured to detect impedance of a tissue section located between theclamp arm 766 and the ultrasonic blade 768 that is indicative of thethickness and/or fullness of tissue located therebetween.

The sensors 788 may be is configured to measure forces exerted on theclamp arm 766 by a closure drive system. For example, one or moresensors 788 can be at an interaction point between a closure tube andthe clamp arm 766 to detect the closure forces applied by a closure tubeto the clamp arm 766. The forces exerted on the clamp arm 766 can berepresentative of the tissue compression experienced by the tissuesection captured between the clamp arm 766 and the ultrasonic blade 768.The one or more sensors 788 can be positioned at various interactionpoints along the closure drive system to detect the closure forcesapplied to the clamp arm 766 by the closure drive system. The one ormore sensors 788 may be sampled in real time during a clamping operationby a processor of the control circuit 760. The control circuit 760receives real-time sample measurements to provide and analyze time-basedinformation and assess, in real time, closure forces applied to theclamp arm 766.

A current sensor 786 can be employed to measure the current drawn by themotor 754. The force required to advance the closure member 764corresponds to the current drawn by the motor 754. The force isconverted to a digital signal and provided to the control circuit 760.

The control circuit 760 can be configured to simulate the response ofthe actual system of the instrument in the software of the controller. Adisplacement member can be actuated to move a closure member 764 in theend effector 752 at or near a target velocity. The surgical instrument750 can include a feedback controller, which can be one of any feedbackcontrollers, including, but not limited to a PID, a state feedback, LQR,and/or an adaptive controller, for example. The surgical instrument 750can include a power source to convert the signal from the feedbackcontroller into a physical input such as case voltage, PWM voltage,frequency modulated voltage, current, torque, and/or force, for example.

The actual drive system of the surgical instrument 750 is configured todrive the displacement member, cutting member, or closure member 764, bya brushed DC motor with gearbox and mechanical links to an articulationand/or knife system. Another example is the electric motor 754 thatoperates the displacement member and the articulation driver, forexample, of an interchangeable shaft assembly. An outside influence isan unmeasured, unpredictable influence of things like tissue,surrounding bodies and friction on the physical system. Such outsideinfluence can be referred to as drag which acts in opposition to theelectric motor 754. The outside influence, such as drag, may cause theoperation of the physical system to deviate from a desired operation ofthe physical system.

Various example aspects are directed to a surgical instrument 750comprising an end effector 752 with motor-driven surgical sealing andcutting implements. For example, a motor 754 may drive a displacementmember distally and proximally along a longitudinal axis of the endeffector 752. The end effector 752 may comprise a pivotable clamp arm766 and, when configured for use, an ultrasonic blade 768 positionedopposite the clamp arm 766. A clinician may grasp tissue between theclamp arm 766 and the ultrasonic blade 768, as described herein. Whenready to use the instrument 750, the clinician may provide a firingsignal, for example by depressing a trigger of the instrument 750. Inresponse to the firing signal, the motor 754 may drive the displacementmember distally along the longitudinal axis of the end effector 752 froma proximal stroke begin position to a stroke end position distal of thestroke begin position. As the displacement member translates distally,the closure member 764 with a cutting element positioned at a distalend, may cut the tissue between the ultrasonic blade 768 and the clamparm 766.

In various examples, the surgical instrument 750 may comprise a controlcircuit 760 programmed to control the distal translation of thedisplacement member, such as the closure member 764, for example, basedon one or more tissue conditions. The control circuit 760 may beprogrammed to sense tissue conditions, such as thickness, eitherdirectly or indirectly, as described herein. The control circuit 760 maybe programmed to select a control program based on tissue conditions. Acontrol program may describe the distal motion of the displacementmember. Different control programs may be selected to better treatdifferent tissue conditions. For example, when thicker tissue ispresent, the control circuit 760 may be programmed to translate thedisplacement member at a lower velocity and/or with lower power. Whenthinner tissue is present, the control circuit 760 may be programmed totranslate the displacement member at a higher velocity and/or withhigher power.

In some examples, the control circuit 760 may initially operate themotor 754 in an open loop configuration for a first open loop portion ofa stroke of the displacement member. Based on a response of theinstrument 750 during the open loop portion of the stroke, the controlcircuit 760 may select a firing control program. The response of theinstrument may include, a translation distance of the displacementmember during the open loop portion, a time elapsed during the open loopportion, energy provided to the motor 754 during the open loop portion,a sum of pulse widths of a motor drive signal, etc. After the open loopportion, the control circuit 760 may implement the selected firingcontrol program for a second portion of the displacement member stroke.For example, during the closed loop portion of the stroke, the controlcircuit 760 may modulate the motor 754 based on translation datadescribing a position of the displacement member in a closed loop mannerto translate the displacement member at a constant velocity. Additionaldetails are disclosed in U.S. patent application Ser. No. 15/720,852,titled SYSTEM AND METHODS FOR CONTROLLING A DISPLAY OF A SURGICALINSTRUMENT, filed Sep. 29, 2017, which is herein incorporated byreference in its entirety.

FIG. 17 is a schematic diagram of a surgical instrument 790 configuredto control various functions according to one aspect of this disclosure.In one aspect, the surgical instrument 790 is programmed to controldistal translation of a displacement member such as the closure member764. The surgical instrument 790 comprises an end effector 792 that maycomprise a clamp arm 766, a closure member 764, and an ultrasonic blade768 which may be interchanged with or work in conjunction with one ormore RF electrodes 796 (shown in dashed line). The ultrasonic blade 768is coupled to an ultrasonic transducer 769 driven by an ultrasonicgenerator 771.

In one aspect, sensors 788 may be implemented as a limit switch,electromechanical device, solid-state switches, Hall-effect devices, MRdevices, GMR devices, magnetometers, among others. In otherimplementations, the sensors 638 may be solid-state switches thatoperate under the influence of light, such as optical sensors, IRsensors, ultraviolet sensors, among others. Still, the switches may besolid-state devices such as transistors (e.g., FET, junction FET,MOSFET, bipolar, and the like). In other implementations, the sensors788 may include electrical conductorless switches, ultrasonic switches,accelerometers, and inertial sensors, among others.

In one aspect, the position sensor 784 may be implemented as an absolutepositioning system comprising a magnetic rotary absolute positioningsystem implemented as an AS5055EQFT single-chip magnetic rotary positionsensor available from Austria Microsystems, AG. The position sensor 784may interface with the control circuit 760 to provide an absolutepositioning system. The position may include multiple Hall-effectelements located above a magnet and coupled to a CORDIC processor, alsoknown as the digit-by-digit method and Volder's algorithm, that isprovided to implement a simple and efficient algorithm to calculatehyperbolic and trigonometric functions that require only addition,subtraction, bitshift, and table lookup operations.

In some examples, the position sensor 784 may be omitted. Where themotor 754 is a stepper motor, the control circuit 760 may track theposition of the closure member 764 by aggregating the number anddirection of steps that the motor has been instructed to execute. Theposition sensor 784 may be located in the end effector 792 or at anyother portion of the instrument.

The control circuit 760 may be in communication with one or more sensors788. The sensors 788 may be positioned on the end effector 792 andadapted to operate with the surgical instrument 790 to measure thevarious derived parameters such as gap distance versus time, tissuecompression versus time, and anvil strain versus time. The sensors 788may comprise a magnetic sensor, a magnetic field sensor, a strain gauge,a pressure sensor, a force sensor, an inductive sensor such as an eddycurrent sensor, a resistive sensor, a capacitive sensor, an opticalsensor, and/or any other suitable sensor for measuring one or moreparameters of the end effector 792. The sensors 788 may include one ormore sensors.

An RF energy source 794 is coupled to the end effector 792 and isapplied to the RF electrode 796 when the RF electrode 796 is provided inthe end effector 792 in place of the ultrasonic blade 768 or to work inconjunction with the ultrasonic blade 768. For example, the ultrasonicblade is made of electrically conductive metal and may be employed asthe return path for electrosurgical RF current. The control circuit 760controls the delivery of the RF energy to the RF electrode 796.

Additional details are disclosed in U.S. patent application Ser. No.15/636,096, titled SURGICAL SYSTEM COUPLABLE WITH STAPLE CARTRIDGE ANDRADIO FREQUENCY CARTRIDGE, AND METHOD OF USING SAME, filed Jun. 28,2017, which is herein incorporated by reference in its entirety.

Generator Hardware Adaptive Ultrasonic Blade Control Algorithms

In various aspects smart ultrasonic energy devices may comprise adaptivealgorithms to control the operation of the ultrasonic blade. In oneaspect, the ultrasonic blade adaptive control algorithms are configuredto identify tissue type and adjust device parameters. In one aspect, theultrasonic blade control algorithms are configured to parameterizetissue type. An algorithm to detect the collagen/elastic ratio of tissueto tune the amplitude of the distal tip of the ultrasonic blade isdescribed in the following section of the present disclosure. Variousaspects of smart ultrasonic energy devices are described herein inconnection with FIGS. 1-106, for example. Accordingly, the followingdescription of adaptive ultrasonic blade control algorithms should beread in conjunction with FIGS. 1-106 and the description associatedtherewith.

Tissue Type Identification and Device Parameter Adjustments

In certain surgical procedures it would be desirable to employ adaptiveultrasonic blade control algorithms. In one aspect, adaptive ultrasonicblade control algorithms may be employed to adjust the parameters of theultrasonic device based on the type of tissue in contact with theultrasonic blade. In one aspect, the parameters of the ultrasonic devicemay be adjusted based on the location of the tissue within the jaws ofthe ultrasonic end effector, for example, the location of the tissuebetween the clamp arm and the ultrasonic blade. The impedance of theultrasonic transducer may be employed to differentiate what percentageof the tissue is located in the distal or proximal end of the endeffector. The reactions of the ultrasonic device may be based on thetissue type or compressibility of the tissue. In another aspect, theparameters of the ultrasonic device may be adjusted based on theidentified tissue type or parameterization. For example, the mechanicaldisplacement amplitude of the distal tip of the ultrasonic blade may betuned based on the ration of collagen to elastin tissue detected duringthe tissue identification procedure. The ratio of collagen to elastintissue may be detected used a variety of techniques including infrared(IR) surface reflectance and emissivity. The force applied to the tissueby the clamp arm and/or the stroke of the clamp arm to produce gap andcompression. Electrical continuity across a jaw equipped with electrodesmay be employed to determine what percentage of the jaw is covered withtissue.

FIG. 18 is a system 800 configured to execute adaptive ultrasonic bladecontrol algorithms in a surgical data network comprising a modularcommunication hub, in accordance with at least one aspect of the presentdisclosure. In one aspect, the generator module 240 is configured toexecute the adaptive ultrasonic blade control algorithm(s) 802 asdescribed herein with reference to FIGS. 53-105. In another aspect, thedevice/instrument 235 is configured to execute the adaptive ultrasonicblade control algorithm(s) 804 as described herein with reference toFIGS. 53-105. In another aspect, both the device/instrument 235 and thedevice/instrument 235 are configured to execute the adaptive ultrasonicblade control algorithms 802, 804 as described herein with reference toFIGS. 53-105.

The generator module 240 may comprise a patient isolated stage incommunication with a non-isolated stage via a power transformer. Asecondary winding of the power transformer is contained in the isolatedstage and may comprise a tapped configuration (e.g., a center-tapped ora non-center-tapped configuration) to define drive signal outputs fordelivering drive signals to different surgical instruments, such as, forexample, an ultrasonic surgical instrument, an RF electrosurgicalinstrument, and a multifunction surgical instrument which includesultrasonic and RF energy modes that can be delivered alone orsimultaneously. In particular, the drive signal outputs may output anultrasonic drive signal (e.g., a 420V root-mean-square (RMS) drivesignal) to an ultrasonic surgical instrument 241, and the drive signaloutputs may output an RF electrosurgical drive signal (e.g., a 100V RMSdrive signal) to an RF electrosurgical instrument 241. Aspects of thegenerator module 240 are described herein with reference to FIGS.21-25B.

The generator module 240 or the device/instrument 235 or both arecoupled to the modular control tower 236 connected to multiple operatingtheater devices such as, for example, intelligent surgical instruments,robots, and other computerized devices located in the operating theater,as described with reference to FIGS. 8-11, for example.

FIG. 19 illustrates an example of a generator 900, which is one form ofa generator configured to couple to an ultrasonic instrument and furtherconfigured to execute adaptive ultrasonic blade control algorithms in asurgical data network comprising a modular communication hub as shown inFIG. 18. The generator 900 is configured to deliver multiple energymodalities to a surgical instrument. The generator 900 provides RF andultrasonic signals for delivering energy to a surgical instrument eitherindependently or simultaneously. The RF and ultrasonic signals may beprovided alone or in combination and may be provided simultaneously. Asnoted above, at least one generator output can deliver multiple energymodalities (e.g., ultrasonic, bipolar or monopolar RF, irreversibleand/or reversible electroporation, and/or microwave energy, amongothers) through a single port, and these signals can be deliveredseparately or simultaneously to the end effector to treat tissue. Thegenerator 900 comprises a processor 902 coupled to a waveform generator904. The processor 902 and waveform generator 904 are configured togenerate a variety of signal waveforms based on information stored in amemory coupled to the processor 902, not shown for clarity ofdisclosure. The digital information associated with a waveform isprovided to the waveform generator 904 which includes one or more DACcircuits to convert the digital input into an analog output. The analogoutput is fed to an amplifier 1106 for signal conditioning andamplification. The conditioned and amplified output of the amplifier 906is coupled to a power transformer 908. The signals are coupled acrossthe power transformer 908 to the secondary side, which is in the patientisolation side. A first signal of a first energy modality is provided tothe surgical instrument between the terminals labeled ENERGY₁ andRETURN. A second signal of a second energy modality is coupled across acapacitor 910 and is provided to the surgical instrument between theterminals labeled ENERGY₂ and RETURN. It will be appreciated that morethan two energy modalities may be output and thus the subscript “n” maybe used to designate that up to n ENERGY_(n) terminals may be provided,where n is a positive integer greater than 1. It also will beappreciated that up to “n” return paths RETURN_(n) may be providedwithout departing from the scope of the present disclosure.

A first voltage sensing circuit 912 is coupled across the terminalslabeled ENERGY₁ and the RETURN path to measure the output voltagetherebetween. A second voltage sensing circuit 924 is coupled across theterminals labeled ENERGY₂ and the RETURN path to measure the outputvoltage therebetween. A current sensing circuit 914 is disposed inseries with the RETURN leg of the secondary side of the powertransformer 908 as shown to measure the output current for either energymodality. If different return paths are provided for each energymodality, then a separate current sensing circuit should be provided ineach return leg. The outputs of the first and second voltage sensingcircuits 912, 924 are provided to respective isolation transformers 916,922 and the output of the current sensing circuit 914 is provided toanother isolation transformer 918. The outputs of the isolationtransformers 916, 928, 922 in the on the primary side of the powertransformer 908 (non-patient isolated side) are provided to a one ormore ADC circuit 926. The digitized output of the ADC circuit 926 isprovided to the processor 902 for further processing and computation.The output voltages and output current feedback information can beemployed to adjust the output voltage and current provided to thesurgical instrument and to compute output impedance, among otherparameters. Input/output communications between the processor 902 andpatient isolated circuits is provided through an interface circuit 920.Sensors also may be in electrical communication with the processor 902by way of the interface circuit 920.

In one aspect, the impedance may be determined by the processor 902 bydividing the output of either the first voltage sensing circuit 912coupled across the terminals labeled ENERGY₁/RETURN or the secondvoltage sensing circuit 924 coupled across the terminals labeledENERGY₂/RETURN by the output of the current sensing circuit 914 disposedin series with the RETURN leg of the secondary side of the powertransformer 908. The outputs of the first and second voltage sensingcircuits 912, 924 are provided to separate isolations transformers 916,922 and the output of the current sensing circuit 914 is provided toanother isolation transformer 916. The digitized voltage and currentsensing measurements from the ADC circuit 926 are provided the processor902 for computing impedance. As an example, the first energy modalityENERGY₁ may be ultrasonic energy and the second energy modality ENERGY₂may be RF energy. Nevertheless, in addition to ultrasonic and bipolar ormonopolar RF energy modalities, other energy modalities includeirreversible and/or reversible electroporation and/or microwave energy,among others. Also, although the example illustrated in FIG. 19 shows asingle return path RETURN may be provided for two or more energymodalities, in other aspects, multiple return paths RETURN_(n) may beprovided for each energy modality ENERGY_(n). Thus, as described herein,the ultrasonic transducer impedance may be measured by dividing theoutput of the first voltage sensing circuit 912 by the current sensingcircuit 914 and the tissue impedance may be measured by dividing theoutput of the second voltage sensing circuit 924 by the current sensingcircuit 914.

As shown in FIG. 19, the generator 900 comprising at least one outputport can include a power transformer 908 with a single output and withmultiple taps to provide power in the form of one or more energymodalities, such as ultrasonic, bipolar or monopolar RF, irreversibleand/or reversible electroporation, and/or microwave energy, amongothers, for example, to the end effector depending on the type oftreatment of tissue being performed. For example, the generator 900 candeliver energy with higher voltage and lower current to drive anultrasonic transducer, with lower voltage and higher current to drive RFelectrodes for sealing tissue, or with a coagulation waveform for spotcoagulation using either monopolar or bipolar RF electrosurgicalelectrodes. The output waveform from the generator 900 can be steered,switched, or filtered to provide the frequency to the end effector ofthe surgical instrument. The connection of an ultrasonic transducer tothe generator 900 output would be preferably located between the outputlabeled ENERGY₁ and RETURN as shown in FIG. 19. In one example, aconnection of RF bipolar electrodes to the generator 900 output would bepreferably located between the output labeled ENERGY₂ and RETURN. In thecase of monopolar output, the preferred connections would be activeelectrode (e.g., pencil or other probe) to the ENERGY₂ output and asuitable return pad connected to the RETURN output.

Additional details are disclosed in U.S. Patent Application PublicationNo. 2017/0086914, titled TECHNIQUES FOR OPERATING GENERATOR FORDIGITALLY GENERATING ELECTRICAL SIGNAL WAVEFORMS AND SURGICALINSTRUMENTS, which published on Mar. 30, 2017, which is hereinincorporated by reference in its entirety.

As used throughout this description, the term “wireless” and itsderivatives may be used to describe circuits, devices, systems, methods,techniques, communications channels, etc., that may communicate datathrough the use of modulated electromagnetic radiation through anon-solid medium. The term does not imply that the associated devices donot contain any wires, although in some aspects they might not. Thecommunication module may implement any of a number of wireless or wiredcommunication standards or protocols, including but not limited to Wi-Fi(IEEE 802.11 family), WiMAX (IEEE 802.16 family), IEEE 802.20, long termevolution (LTE), Ev-DO, HSPA+, HSDPA+, HSUPA+, EDGE, GSM, GPRS, CDMA,TDMA, DECT, Bluetooth, Ethernet derivatives thereof, as well as anyother wireless and wired protocols that are designated as 3G, 4G, 5G,and beyond. The computing module may include a plurality ofcommunication modules. For instance, a first communication module may bededicated to shorter range wireless communications such as Wi-Fi andBluetooth and a second communication module may be dedicated to longerrange wireless communications such as GPS, EDGE, GPRS, CDMA, WiMAX, LTE,Ev-DO, and others.

As used herein a processor or processing unit is an electronic circuitwhich performs operations on some external data source, usually memoryor some other data stream. The term is used herein to refer to thecentral processor (central processing unit) in a system or computersystems (especially systems on a chip (SoCs)) that combine a number ofspecialized “processors.”

As used herein, a system on a chip or system on chip (SoC or SOC) is anintegrated circuit (also known as an “IC” or “chip”) that integrates allcomponents of a computer or other electronic systems. It may containdigital, analog, mixed-signal, and often radio-frequency functions—allon a single substrate. A SoC integrates a microcontroller (ormicroprocessor) with advanced peripherals like graphics processing unit(GPU), Wi-Fi module, or coprocessor. A SoC may or may not containbuilt-in memory.

As used herein, a microcontroller or controller is a system thatintegrates a microprocessor with peripheral circuits and memory. Amicrocontroller (or MCU for microcontroller unit) may be implemented asa small computer on a single integrated circuit. It may be similar to aSoC; an SoC may include a microcontroller as one of its components. Amicrocontroller may contain one or more core processing units (CPUs)along with memory and programmable input/output peripherals. Programmemory in the form of Ferroelectric RAM, NOR flash or OTP ROM is alsooften included on chip, as well as a small amount of RAM.Microcontrollers may be employed for embedded applications, in contrastto the microprocessors used in personal computers or other generalpurpose applications consisting of various discrete chips.

As used herein, the term controller or microcontroller may be astand-alone IC or chip device that interfaces with a peripheral device.This may be a link between two parts of a computer or a controller on anexternal device that manages the operation of (and connection with) thatdevice.

Any of the processors or microcontrollers described herein, may beimplemented by any single core or multicore processor such as thoseknown under the trade name ARM Cortex by Texas Instruments. In oneaspect, the processor may be an LM4F230H5QR ARM Cortex-M4F ProcessorCore, available from Texas Instruments, for example, comprising on-chipmemory of 256 KB single-cycle flash memory, or other non-volatilememory, up to 40 MHz, a prefetch buffer to improve performance above 40MHz, a 32 KB single-cycle serial random access memory (SRAM), internalread-only memory (ROM) loaded with StellarisWare® software, 2 KBelectrically erasable programmable read-only memory (EEPROM), one ormore pulse width modulation (PWM) modules, one or more quadratureencoder inputs (QEI) analog, one or more 12-bit Analog-to-DigitalConverters (ADC) with 12 analog input channels, details of which areavailable for the product datasheet.

In one aspect, the processor may comprise a safety controller comprisingtwo controller-based families such as TMS570 and RM4x known under thetrade name Hercules ARM Cortex R4, also by Texas Instruments. The safetycontroller may be configured specifically for IEC 61508 and ISO 26262safety critical applications, among others, to provide advancedintegrated safety features while delivering scalable performance,connectivity, and memory options.

Modular devices include the modules (as described in connection withFIGS. 3 and 9, for example) that are receivable within a surgical huband the surgical devices or instruments that can be connected to thevarious modules in order to connect or pair with the correspondingsurgical hub. The modular devices include, for example, intelligentsurgical instruments, medical imaging devices, suction/irrigationdevices, smoke evacuators, energy generators, ventilators, insufflators,and displays. The modular devices described herein can be controlled bycontrol algorithms. The control algorithms can be executed on themodular device itself, on the surgical hub to which the particularmodular device is paired, or on both the modular device and the surgicalhub (e.g., via a distributed computing architecture). In someexemplifications, the modular devices' control algorithms control thedevices based on data sensed by the modular device itself (i.e., bysensors in, on, or connected to the modular device). This data can berelated to the patient being operated on (e.g., tissue properties orinsufflation pressure) or the modular device itself (e.g., the rate atwhich a knife is being advanced, motor current, or energy levels). Forexample, a control algorithm for a surgical stapling and cuttinginstrument can control the rate at which the instrument's motor drivesits knife through tissue according to resistance encountered by theknife as it advances.

FIG. 20 illustrates one form of a surgical system 1000 comprising agenerator 1100 and various surgical instruments 1104, 1106, 1108 usabletherewith, where the surgical instrument 1104 is an ultrasonic surgicalinstrument, the surgical instrument 1106 is an RF electrosurgicalinstrument, and the multifunction surgical instrument 1108 is acombination ultrasonic/RF electrosurgical instrument. The generator 1100is configurable for use with a variety of surgical instruments.According to various forms, the generator 1100 may be configurable foruse with different surgical instruments of different types including,for example, ultrasonic surgical instruments 1104, RF electrosurgicalinstruments 1106, and multifunction surgical instruments 1108 thatintegrate RF and ultrasonic energies delivered simultaneously from thegenerator 1100. Although in the form of FIG. 20 the generator 1100 isshown separate from the surgical instruments 1104, 1106, 1108 in oneform, the generator 1100 may be formed integrally with any of thesurgical instruments 1104, 1106, 1108 to form a unitary surgical system.The generator 1100 comprises an input device 1110 located on a frontpanel of the generator 1100 console. The input device 1110 may compriseany suitable device that generates signals suitable for programming theoperation of the generator 1100. The generator 1100 may be configuredfor wired or wireless communication.

The generator 1100 is configured to drive multiple surgical instruments1104, 1106, 1108. The first surgical instrument is an ultrasonicsurgical instrument 1104 and comprises a handpiece 1105 (HP), anultrasonic transducer 1120, a shaft 1126, and an end effector 1122. Theend effector 1122 comprises an ultrasonic blade 1128 acousticallycoupled to the ultrasonic transducer 1120 and a clamp arm 1140. Thehandpiece 1105 comprises a trigger 1143 to operate the clamp arm 1140and a combination of the toggle buttons 1134 a, 1134 b, 1134 c toenergize and drive the ultrasonic blade 1128 or other function. Thetoggle buttons 1134 a, 1134 b, 1134 c can be configured to energize theultrasonic transducer 1120 with the generator 1100.

The generator 1100 also is configured to drive a second surgicalinstrument 1106. The second surgical instrument 1106 is an RFelectrosurgical instrument and comprises a handpiece 1107 (HP), a shaft1127, and an end effector 1124. The end effector 1124 compriseselectrodes in clamp arms 1142 a, 1142 b and return through an electricalconductor portion of the shaft 1127. The electrodes are coupled to andenergized by a bipolar energy source within the generator 1100. Thehandpiece 1107 comprises a trigger 1145 to operate the clamp arms 1142a, 1142 b and an energy button 1135 to actuate an energy switch toenergize the electrodes in the end effector 1124.

The generator 1100 also is configured to drive a multifunction surgicalinstrument 1108. The multifunction surgical instrument 1108 comprises ahandpiece 1109 (HP), a shaft 1129, and an end effector 1125. The endeffector 1125 comprises an ultrasonic blade 1149 and a clamp arm 1146.The ultrasonic blade 1149 is acoustically coupled to the ultrasonictransducer 1120. The handpiece 1109 comprises a trigger 1147 to operatethe clamp arm 1146 and a combination of the toggle buttons 1137 a, 1137b, 1137 c to energize and drive the ultrasonic blade 1149 or otherfunction. The toggle buttons 1137 a, 1137 b, 1137 c can be configured toenergize the ultrasonic transducer 1120 with the generator 1100 andenergize the ultrasonic blade 1149 with a bipolar energy source alsocontained within the generator 1100.

The generator 1100 is configurable for use with a variety of surgicalinstruments. According to various forms, the generator 1100 may beconfigurable for use with different surgical instruments of differenttypes including, for example, the ultrasonic surgical instrument 1104,the RF electrosurgical instrument 1106, and the multifunction surgicalinstrument 1108 that integrates RF and ultrasonic energies deliveredsimultaneously from the generator 1100. Although in the form of FIG. 20the generator 1100 is shown separate from the surgical instruments 1104,1106, 1108, in another form the generator 1100 may be formed integrallywith any one of the surgical instruments 1104, 1106, 1108 to form aunitary surgical system. As discussed above, the generator 1100comprises an input device 1110 located on a front panel of the generator1100 console. The input device 1110 may comprise any suitable devicethat generates signals suitable for programming the operation of thegenerator 1100. The generator 1100 also may comprise one or more outputdevices 1112. Further aspects of generators for digitally generatingelectrical signal waveforms and surgical instruments are described in USpatent publication US-2017-0086914-A1, which is herein incorporated byreference in its entirety.

FIG. 21 is an end effector 1122 of the example ultrasonic device 1104,in accordance with at least one aspect of the present disclosure. Theend effector 1122 may comprise a blade 1128 that may be coupled to theultrasonic transducer 1120 via a wave guide. When driven by theultrasonic transducer 1120, the blade 1128 may vibrate and, when broughtinto contact with tissue, may cut and/or coagulate the tissue, asdescribed herein. According to various aspects, and as illustrated inFIG. 21, the end effector 1122 may also comprise a clamp arm 1140 thatmay be configured for cooperative action with the blade 1128 of the endeffector 1122. With the blade 1128, the clamp arm 1140 may comprise aset of jaws. The clamp arm 1140 may be pivotally connected at a distalend of a shaft 1126 of the instrument portion 1104. The clamp arm 1140may include a clamp arm tissue pad 1163, which may be formed fromTEFLON® or other suitable low-friction material. The pad 1163 may bemounted for cooperation with the blade 1128, with pivotal movement ofthe clamp arm 1140 positioning the clamp pad 1163 in substantiallyparallel relationship to, and in contact with, the blade 1128. By thisconstruction, a tissue bite to be clamped may be grasped between thetissue pad 1163 and the blade 1128. The tissue pad 1163 may be providedwith a sawtooth-like configuration including a plurality of axiallyspaced, proximally extending gripping teeth 1161 to enhance the grippingof tissue in cooperation with the blade 1128. The clamp arm 1140 maytransition from the open position shown in FIG. 21 to a closed position(with the clamp arm 1140 in contact with or proximity to the blade 1128)in any suitable manner. For example, the handpiece 1105 may comprise ajaw closure trigger. When actuated by a clinician, the jaw closuretrigger may pivot the clamp arm 1140 in any suitable manner.

The generator 1100 may be activated to provide the drive signal to theultrasonic transducer 1120 in any suitable manner. For example, thegenerator 1100 may comprise a foot switch 1430 (FIG. 24) coupled to thegenerator 1100 via a footswitch cable 1432. A clinician may activate theultrasonic transducer 1120, and thereby the ultrasonic transducer 1120and blade 1128, by depressing the foot switch 1430. In addition, orinstead of the foot switch 1430, some aspects of the device 1104 mayutilize one or more switches positioned on the handpiece 1105 that, whenactivated, may cause the generator 1100 to activate the ultrasonictransducer 1120. In one aspect, for example, the one or more switchesmay comprise a pair of toggle buttons 1134 a, 1134 b, 1134 c (FIG. 20),for example, to determine an operating mode of the device 1104. When thetoggle button 1134 a is depressed, for example, the ultrasonic generator1100 may provide a maximum drive signal to the ultrasonic transducer1120, causing it to produce maximum ultrasonic energy output. Depressingtoggle button 1134 b may cause the ultrasonic generator 1100 to providea user-selectable drive signal to the ultrasonic transducer 1120,causing it to produce less than the maximum ultrasonic energy output.The device 1104 additionally or alternatively may comprise a secondswitch to, for example, indicate a position of a jaw closure trigger foroperating the jaws via the clamp arm 1140 of the end effector 1122.Also, in some aspects, the ultrasonic generator 1100 may be activatedbased on the position of the jaw closure trigger, (e.g., as theclinician depresses the jaw closure trigger to close the jaws via theclamp arm 1140, ultrasonic energy may be applied).

Additionally or alternatively, the one or more switches may comprise atoggle button 1134 c that, when depressed, causes the generator 1100 toprovide a pulsed output (FIG. 20). The pulses may be provided at anysuitable frequency and grouping, for example. In certain aspects, thepower level of the pulses may be the power levels associated with togglebuttons 1134 a, 1134 b (maximum, less than maximum), for example.

It will be appreciated that a device 1104 may comprise any combinationof the toggle buttons 1134 a, 1134 b, 1134 c (FIG. 20). For example, thedevice 1104 could be configured to have only two toggle buttons: atoggle button 1134 a for producing maximum ultrasonic energy output anda toggle button 1134 c for producing a pulsed output at either themaximum or less than maximum power level per. In this way, the drivesignal output configuration of the generator 1100 could be fivecontinuous signals, or any discrete number of individual pulsed signals(1, 2, 3, 4, or 5). In certain aspects, the specific drive signalconfiguration may be controlled based upon, for example, EEPROM settingsin the generator 1100 and/or user power level selection(s).

In certain aspects, a two-position switch may be provided as analternative to a toggle button 1134 c (FIG. 20). For example, a device1104 may include a toggle button 1134 a for producing a continuousoutput at a maximum power level and a two-position toggle button 1134 b.In a first detented position, toggle button 1134 b may produce acontinuous output at a less than maximum power level, and in a seconddetented position the toggle button 1134 b may produce a pulsed output(e.g., at either a maximum or less than maximum power level, dependingupon the EEPROM settings).

In some aspects, the RF electrosurgical end effector 1124, 1125 (FIG.20) may also comprise a pair of electrodes. The electrodes may be incommunication with the generator 1100, for example, via a cable. Theelectrodes may be used, for example, to measure an impedance of a tissuebite present between the clamp arm 1142 a, 1146 and the blade 1142 b,1149. The generator 1100 may provide a signal (e.g., a non-therapeuticsignal) to the electrodes. The impedance of the tissue bite may befound, for example, by monitoring the current, voltage, etc. of thesignal.

In accordance with the described aspects, the ultrasonic generatormodule may produce a drive signal or signals of particular voltages,currents, and frequencies (e.g. 55,500 cycles per second, or Hz). Thedrive signal or signals may be provided to the ultrasonic device 1104,and specifically to the transducer 1120, which may operate, for example,as described above. In one aspect, the generator 1100 may be configuredto produce a drive signal of a particular voltage, current, and/orfrequency output signal that can be stepped with high resolution,accuracy, and repeatability.

In accordance with the described aspects, the electrosurgery/RFgenerator module may generate a drive signal or signals with outputpower sufficient to perform bipolar electrosurgery using radio frequency(RF) energy. In bipolar electrosurgery applications, the drive signalmay be provided, for example, to the electrodes of the electrosurgicaldevice 1106, for example, as described above. Accordingly, the generator1100 may be configured for therapeutic purposes by applying electricalenergy to the tissue sufficient for treating the tissue (e.g.,coagulation, cauterization, tissue welding, etc.).

The generator 1100 may comprise an input device 2150 (FIG. 24B) located,for example, on a front panel of the generator 1100 console. The inputdevice 2150 may comprise any suitable device that generates signalssuitable for programming the operation of the generator 1100. Inoperation, the user can program or otherwise control operation of thegenerator 1100 using the input device 2150. The input device 2150 maycomprise any suitable device that generates signals that can be used bythe generator (e.g., by one or more processors contained in thegenerator) to control the operation of the generator 1100 (e.g.,operation of the ultrasonic generator module and/or electrosurgery/RFgenerator module). In various aspects, the input device 2150 includesone or more of: buttons, switches, thumbwheels, keyboard, keypad, touchscreen monitor, pointing device, remote connection to a general purposeor dedicated computer. In other aspects, the input device 2150 maycomprise a suitable user interface, such as one or more user interfacescreens displayed on a touch screen monitor, for example. Accordingly,by way of the input device 2150, the user can set or program variousoperating parameters of the generator, such as, for example, current(I), voltage (V), frequency (f), and/or period (T) of a drive signal orsignals generated by the ultrasonic generator module and/orelectrosurgery/RF generator module.

The generator 1100 may also comprise an output device 2140 (FIG. 24B)located, for example, on a front panel of the generator 1100 console.The output device 2140 includes one or more devices for providing asensory feedback to a user. Such devices may comprise, for example,visual feedback devices (e.g., an LCD display screen, LED indicators),audio feedback devices (e.g., a speaker, a buzzer) or tactile feedbackdevices (e.g., haptic actuators).

Although certain modules and/or blocks of the generator 1100 may bedescribed by way of example, it can be appreciated that a greater orlesser number of modules and/or blocks may be used and still fall withinthe scope of the aspects. Further, although various aspects may bedescribed in terms of modules and/or blocks to facilitate description,such modules and/or blocks may be implemented by one or more hardwarecomponents, e.g., processors, Digital Signal Processors (DSPs),Programmable Logic Devices (PLDs), Application Specific IntegratedCircuits (ASICs), circuits, registers and/or software components, e.g.,programs, subroutines, logic and/or combinations of hardware andsoftware components.

In one aspect, the ultrasonic generator drive module andelectrosurgery/RF drive module 1110 (FIG. 20) may comprise one or moreembedded applications implemented as firmware, software, hardware, orany combination thereof. The modules may comprise various executablemodules such as software, programs, data, drivers, application programinterfaces (APIs), and so forth. The firmware may be stored innonvolatile memory (NVM), such as in bit-masked read-only memory (ROM)or flash memory. In various implementations, storing the firmware in ROMmay preserve flash memory. The NVM may comprise other types of memoryincluding, for example, programmable ROM (PROM), erasable programmableROM (EPROM), electrically erasable programmable ROM (EEPROM), or batterybacked random-access memory (RAM) such as dynamic RAM (DRAM),Double-Data-Rate DRAM (DDRAM), and/or synchronous DRAM (SDRAM).

In one aspect, the modules comprise a hardware component implemented asa processor for executing program instructions for monitoring variousmeasurable characteristics of the devices 1104, 1106, 1108 andgenerating a corresponding output drive signal or signals for operatingthe devices 1104, 1106, 1108. In aspects in which the generator 1100 isused in conjunction with the device 1104, the drive signal may drive theultrasonic transducer 1120 in cutting and/or coagulation operatingmodes. Electrical characteristics of the device 1104 and/or tissue maybe measured and used to control operational aspects of the generator1100 and/or provided as feedback to the user. In aspects in which thegenerator 1100 is used in conjunction with the device 1106, the drivesignal may supply electrical energy (e.g., RF energy) to the endeffector 1124 in cutting, coagulation and/or desiccation modes.Electrical characteristics of the device 1106 and/or tissue may bemeasured and used to control operational aspects of the generator 1100and/or provided as feedback to the user. In various aspects, aspreviously discussed, the hardware components may be implemented as DSP,PLD, ASIC, circuits, and/or registers. In one aspect, the processor maybe configured to store and execute computer software programinstructions to generate the step function output signals for drivingvarious components of the devices 1104, 1106, 1108, such as theultrasonic transducer 1120 and the end effectors 1122, 1124, 1125.

An electromechanical ultrasonic system includes an ultrasonictransducer, a waveguide, and an ultrasonic blade. The electromechanicalultrasonic system has an initial resonant frequency defined by thephysical properties of the ultrasonic transducer, the waveguide, and theultrasonic blade. The ultrasonic transducer is excited by an alternatingvoltage V_(g)(t) and current I_(g)(t) signal equal to the resonantfrequency of the electromechanical ultrasonic system. When theelectromechanical ultrasonic system is at resonance, the phasedifference between the voltage V_(g)(t) and current I_(g)(t) signals iszero. Stated another way, at resonance the inductive impedance is equalto the capacitive impedance. As the ultrasonic blade heats up, thecompliance of the ultrasonic blade (modeled as an equivalentcapacitance) causes the resonant frequency of the electromechanicalultrasonic system to shift. Thus, the inductive impedance is no longerequal to the capacitive impedance causing a mismatch between the drivefrequency and the resonant frequency of the electromechanical ultrasonicsystem. The system is now operating “off-resonance.” The mismatchbetween the drive frequency and the resonant frequency is manifested asa phase difference between the voltage V_(g)(t) and current I_(g)(t)signals applied to the ultrasonic transducer. The generator electronicscan easily monitor the phase difference between the voltage V_(g)(t) andcurrent I_(g)(t) signals and can continuously adjust the drive frequencyuntil the phase difference is once again zero. At this point, the newdrive frequency is equal to the new resonant frequency of theelectromechanical ultrasonic system. The change in phase and/orfrequency can be used as an indirect measurement of the ultrasonic bladetemperature.

As shown in FIG. 22, the electromechanical properties of the ultrasonictransducer may be modeled as an equivalent circuit comprising a firstbranch having a static capacitance and a second “motional” branch havinga serially connected inductance, resistance and capacitance that definethe electromechanical properties of a resonator. Known ultrasonicgenerators may include a tuning inductor for tuning out the staticcapacitance at a resonant frequency so that substantially all ofgenerator's drive signal current flows into the motional branch.Accordingly, by using a tuning inductor, the generator's drive signalcurrent represents the motional branch current, and the generator isthus able to control its drive signal to maintain the ultrasonictransducer's resonant frequency. The tuning inductor may also transformthe phase impedance plot of the ultrasonic transducer to improve thegenerator's frequency lock capabilities. However, the tuning inductormust be matched with the specific static capacitance of an ultrasonictransducer at the operational resonance frequency. In other words, adifferent ultrasonic transducer having a different static capacitancerequires a different tuning inductor.

FIG. 22 illustrates an equivalent circuit 1500 of an ultrasonictransducer, such as the ultrasonic transducer 1120, according to oneaspect. The circuit 1500 comprises a first “motional” branch having aserially connected inductance L_(s), resistance R_(s) and capacitanceC_(s) that define the electromechanical properties of the resonator, anda second capacitive branch having a static capacitance C₀. Drive currentI_(g)(t) may be received from a generator at a drive voltage V_(g)(t),with motional current I_(m)(t) flowing through the first branch andcurrent I_(g)(t)-I_(m)(t) flowing through the capacitive branch. Controlof the electromechanical properties of the ultrasonic transducer may beachieved by suitably controlling I_(g)(t) and V_(g)(t). As explainedabove, known generator architectures may include a tuning inductor L_(t)(shown in phantom in FIG. 22) in a parallel resonance circuit for tuningout the static capacitance C₀ at a resonant frequency so thatsubstantially all of the generator's current output I_(g)(t) flowsthrough the motional branch. In this way, control of the motional branchcurrent I_(m)(t) is achieved by controlling the generator current outputI_(g)(t). The tuning inductor L_(t) is specific to the staticcapacitance C₀ of an ultrasonic transducer, however, and a differentultrasonic transducer having a different static capacitance requires adifferent tuning inductor L_(t). Moreover, because the tuning inductorL_(t) is matched to the nominal value of the static capacitance C₀ at asingle resonant frequency, accurate control of the motional branchcurrent I_(m)(t) is assured only at that frequency. As frequency shiftsdown with transducer temperature, accurate control of the motionalbranch current is compromised.

Various aspects of the generator 1100 may not rely on a tuning inductorL_(t) to monitor the motional branch current I_(m)(t). Instead, thegenerator 1100 may use the measured value of the static capacitance C₀in between applications of power for a specific ultrasonic surgicaldevice 1104 (along with drive signal voltage and current feedback data)to determine values of the motional branch current I_(m)(t) on a dynamicand ongoing basis (e.g., in real-time). Such aspects of the generator1100 are therefore able to provide virtual tuning to simulate a systemthat is tuned or resonant with any value of static capacitance C₀ at anyfrequency, and not just at a single resonant frequency dictated by anominal value of the static capacitance C₀.

FIG. 23 is a simplified block diagram of one aspect of the generator1100 for providing inductorless tuning as described above, among otherbenefits. FIGS. 24A-24C illustrate an architecture of the generator 1100of FIG. 23 according to one aspect. With reference to FIG. 23, thegenerator 1100 may comprise a patient isolated stage 1520 incommunication with a non-isolated stage 1540 via a power transformer1560. A secondary winding 1580 of the power transformer 1560 iscontained in the isolated stage 1520 and may comprise a tappedconfiguration (e.g., a center-tapped or non-center tapped configuration)to define drive signal outputs 1600 a, 1600 b, 1600 c for outputtingdrive signals to different surgical devices, such as, for example, anultrasonic surgical device 1104 and an electrosurgical device 1106. Inparticular, drive signal outputs 1600 a, 1600 b, 1600 c may output adrive signal (e.g., a 420V RMS drive signal) to an ultrasonic surgicaldevice 1104, and drive signal outputs 1600 a, 1600 b, 1600 c may outputa drive signal (e.g., a 100V RMS drive signal) to an electrosurgicaldevice 1106, with output 1600 b corresponding to the center tap of thepower transformer 1560. The non-isolated stage 1540 may comprise a poweramplifier 1620 having an output connected to a primary winding 1640 ofthe power transformer 1560. In certain aspects the power amplifier 1620may comprise a push-pull amplifier, for example. The non-isolated stage1540 may further comprise a programmable logic device 1660 for supplyinga digital output to a digital-to-analog converter (DAC) 1680, which inturn supplies a corresponding analog signal to an input of the poweramplifier 1620. In certain aspects the programmable logic device 1660may comprise a field-programmable gate array (FPGA), for example. Theprogrammable logic device 1660, by virtue of controlling the poweramplifier's 1620 input via the DAC 1680, may therefore control any of anumber of parameters (e.g., frequency, waveform shape, waveformamplitude) of drive signals appearing at the drive signal outputs 1600a, 1600 b, 1600 c. In certain aspects and as discussed below, theprogrammable logic device 1660, in conjunction with a processor (e.g.,processor 1740 discussed below), may implement a number of digitalsignal processing (DSP)-based and/or other control algorithms to controlparameters of the drive signals output by the generator 1100.

Power may be supplied to a power rail of the power amplifier 1620 by aswitch-mode regulator 1700. In certain aspects the switch-mode regulator1700 may comprise an adjustable buck regulator, for example. Asdiscussed above, the non-isolated stage 1540 may further comprise aprocessor 1740, which in one aspect may comprise a DSP processor such asan ADSP-21469 SHARC DSP, available from Analog Devices, Norwood, Mass.,for example. In certain aspects the processor 1740 may control operationof the switch-mode power converter 1700 responsive to voltage feedbackdata received from the power amplifier 1620 by the processor 1740 via ananalog-to-digital converter (ADC) 1760. In one aspect, for example, theprocessor 1740 may receive as input, via the ADC 1760, the waveformenvelope of a signal (e.g., an RF signal) being amplified by the poweramplifier 1620. The processor 1740 may then control the switch-moderegulator 1700 (e.g., via a pulse-width modulated (PWM) output) suchthat the rail voltage supplied to the power amplifier 1620 tracks thewaveform envelope of the amplified signal. By dynamically modulating therail voltage of the power amplifier 1620 based on the waveform envelope,the efficiency of the power amplifier 1620 may be significantly improvedrelative to a fixed rail voltage amplifier scheme. The processor 1740may be configured for wired or wireless communication.

In certain aspects and as discussed in further detail in connection withFIGS. 25A-25B, the programmable logic device 1660, in conjunction withthe processor 1740, may implement a direct digital synthesizer (DDS)control scheme to control the waveform shape, frequency and/or amplitudeof drive signals output by the generator 1100. In one aspect, forexample, the programmable logic device 1660 may implement a DDS controlalgorithm 2680 (FIG. 25A) by recalling waveform samples stored in adynamically-updated look-up table (LUT), such as a RAM LUT which may beembedded in an FPGA. This control algorithm is particularly useful forultrasonic applications in which an ultrasonic transducer, such as theultrasonic transducer 1120, may be driven by a clean sinusoidal currentat its resonant frequency. Because other frequencies may exciteparasitic resonances, minimizing or reducing the total distortion of themotional branch current may correspondingly minimize or reduceundesirable resonance effects. Because the waveform shape of a drivesignal output by the generator 1100 is impacted by various sources ofdistortion present in the output drive circuit (e.g., the powertransformer 1560, the power amplifier 1620), voltage and currentfeedback data based on the drive signal may be input into an algorithm,such as an error control algorithm implemented by the processor 1740,which compensates for distortion by suitably pre-distorting or modifyingthe waveform samples stored in the LUT on a dynamic, ongoing basis(e.g., in real-time). In one aspect, the amount or degree ofpre-distortion applied to the LUT samples may be based on the errorbetween a computed motional branch current and a desired currentwaveform shape, with the error being determined on a sample-by samplebasis. In this way, the pre-distorted LUT samples, when processedthrough the drive circuit, may result in a motional branch drive signalhaving the desired waveform shape (e.g., sinusoidal) for optimallydriving the ultrasonic transducer. In such aspects, the LUT waveformsamples will therefore not represent the desired waveform shape of thedrive signal, but rather the waveform shape that is required toultimately produce the desired waveform shape of the motional branchdrive signal when distortion effects are taken into account.

The non-isolated stage 1540 may further comprise an ADC 1780 and an ADC1800 coupled to the output of the power transformer 1560 via respectiveisolation transformers 1820, 1840 for respectively sampling the voltageand current of drive signals output by the generator 1100. In certainaspects, the ADCs 1780, 1800 may be configured to sample at high speeds(e.g., 80 Msps) to enable oversampling of the drive signals. In oneaspect, for example, the sampling speed of the ADCs 1780, 1800 mayenable approximately 200× (depending on drive frequency) oversampling ofthe drive signals. In certain aspects, the sampling operations of theADCs 1780, 1800 may be performed by a single ADC receiving input voltageand current signals via a two-way multiplexer. The use of high-speedsampling in aspects of the generator 1100 may enable, among otherthings, calculation of the complex current flowing through the motionalbranch (which may be used in certain aspects to implement DDS-basedwaveform shape control described above), accurate digital filtering ofthe sampled signals, and calculation of real power consumption with ahigh degree of precision. Voltage and current feedback data output bythe ADCs 1780, 1800 may be received and processed (e.g., FIFO buffering,multiplexing) by the programmable logic device 1660 and stored in datamemory for subsequent retrieval by, for example, the processor 1740. Asnoted above, voltage and current feedback data may be used as input toan algorithm for pre-distorting or modifying LUT waveform samples on adynamic and ongoing basis. In certain aspects, this may require eachstored voltage and current feedback data pair to be indexed based on, orotherwise associated with, a corresponding LUT sample that was output bythe programmable logic device 1660 when the voltage and current feedbackdata pair was acquired. Synchronization of the LUT samples and thevoltage and current feedback data in this manner contributes to thecorrect timing and stability of the pre-distortion algorithm.

In certain aspects, the voltage and current feedback data may be used tocontrol the frequency and/or amplitude (e.g., current amplitude) of thedrive signals. In one aspect, for example, voltage and current feedbackdata may be used to determine impedance phase, e.g., the phasedifference between the voltage and current drive signals. The frequencyof the drive signal may then be controlled to minimize or reduce thedifference between the determined impedance phase and an impedance phasesetpoint (e.g., 0°), thereby minimizing or reducing the effects ofharmonic distortion and correspondingly enhancing impedance phasemeasurement accuracy. The determination of phase impedance and afrequency control signal may be implemented in the processor 1740, forexample, with the frequency control signal being supplied as input to aDDS control algorithm implemented by the programmable logic device 1660.

The impedance phase may be determined through Fourier analysis. In oneaspect, the phase difference between the generator voltage V_(g)(t) andgenerator current I_(g)(t) driving signals may be determined using theFast Fourier Transform (FFT) or the Discrete Fourier Transform (DFT) asfollows:

V_(g)(t) = A₁cos (2π f₀t + φ₁) I_(g)(t) = A₂cos (2π f₀t + φ₂)${V_{g}(f)} = {\frac{A_{1}}{2}\left( {{\delta\left( {f - f_{0}} \right)} + {\delta\left( {f + f_{0}} \right)}} \right){\exp\left( {j\; 2\pi\; f\frac{\varphi_{1}}{2\pi\; f_{0}}} \right)}}$${I_{g}(f)} = {\frac{A_{2}}{2}\left( {{\delta\left( {f - f_{0}} \right)} + {\delta\left( {f + f_{0}} \right)}} \right){\exp\left( {j\; 2\pi\; f\frac{\varphi_{2}}{2\pi\; f_{0}}} \right)}}$

Evaluating the Fourier Transform at the frequency of the sinusoidyields:

${V_{g}\left( f_{0} \right)} = {{\frac{A_{1}}{2}{\delta(0)}{\exp\left( {j\;\varphi_{1}} \right)}\mspace{31mu}\arg\;{V\left( f_{0} \right)}} = \varphi_{1}}$${I_{g}\left( f_{0} \right)} = {{\frac{A_{2}}{2}{\delta(0)}{\exp\left( {j\;\varphi_{2}} \right)}\mspace{45mu}\arg\;{I\left( f_{0} \right)}} = \varphi_{2}}$

Other approaches include weighted least-squares estimation, Kalmanfiltering, and space-vector-based techniques. Virtually all of theprocessing in an FFT or DFT technique may be performed in the digitaldomain with the aid of the 2-channel high speed ADC 1780, 1800, forexample. In one technique, the digital signal samples of the voltage andcurrent signals are Fourier transformed with an FFT or a DFT. The phaseangle φ at any point in time can be calculated by:φ=2πft+φ ₀

Where φ is the phase angle, f is the frequency, t is time, and φ₀ is thephase at t=0.

Another technique for determining the phase difference between thevoltage V_(g)(t) and current I_(g)(t) signals is the zero-crossingmethod and produces highly accurate results. For voltage V_(g)(t) andcurrent I_(g)(t) signals having the same frequency, each negative topositive zero-crossing of voltage signal V_(g)(t) triggers the start ofa pulse, while each negative to positive zero-crossing of current signalI_(g)(t) triggers the end of the pulse. The result is a pulse train witha pulse width proportional to the phase angle between the voltage signaland the current signal. In one aspect, the pulse train may be passedthrough an averaging filter to yield a measure of the phase difference.Furthermore, if the positive to negative zero crossings also are used ina similar manner, and the results averaged, any effects of DC andharmonic components can be reduced. In one implementation, the analogvoltage V_(g)(t) and current I_(g)(t) signals are converted to digitalsignals that are high if the analog signal is positive and low if theanalog signal is negative. High accuracy phase estimates require sharptransitions between high and low. In one aspect, a Schmitt trigger alongwith an RC stabilization network may be employed to convert the analogsignals into digital signals. In other aspects, an edge triggered RSflip-flop and ancillary circuitry may be employed. In yet anotheraspect, the zero-crossing technique may employ an eXclusive OR (XOR)gate.

Other techniques for determining the phase difference between thevoltage and current signals include Lissajous figures and monitoring theimage; methods such as the three-voltmeter method, the crossed-coilmethod, vector voltmeter and vector impedance methods; and using phasestandard instruments, phase-locked loops, and other techniques asdescribed in Phase Measurement, Peter O'Shea, 2000 CRC Press LLC,<http://www.engnetbase.com>, which is incorporated herein by reference.

In another aspect, for example, the current feedback data may bemonitored in order to maintain the current amplitude of the drive signalat a current amplitude setpoint. The current amplitude setpoint may bespecified directly or determined indirectly based on specified voltageamplitude and power setpoints. In certain aspects, control of thecurrent amplitude may be implemented by control algorithm, such as, forexample, a proportional-integral-derivative (PID) control algorithm, inthe processor 1740. Variables controlled by the control algorithm tosuitably control the current amplitude of the drive signal may include,for example, the scaling of the LUT waveform samples stored in theprogrammable logic device 1660 and/or the full-scale output voltage ofthe DAC 1680 (which supplies the input to the power amplifier 1620) viaa DAC 1860.

The non-isolated stage 1540 may further comprise a processor 1900 forproviding, among other things, user interface (UI) functionality. In oneaspect, the processor 1900 may comprise an Atmel AT91 SAM9263 processorhaving an ARM 926EJ-S core, available from Atmel Corporation, San Jose,Calif., for example. Examples of UI functionality supported by theprocessor 1900 may include audible and visual user feedback,communication with peripheral devices (e.g., via a Universal Serial Bus(USB) interface), communication with a foot switch 1430, communicationwith an input device 2150 (e.g., a touch screen display) andcommunication with an output device 2140 (e.g., a speaker). Theprocessor 1900 may communicate with the processor 1740 and theprogrammable logic device (e.g., via a serial peripheral interface (SPI)bus). Although the processor 1900 may primarily support UIfunctionality, it may also coordinate with the processor 1740 toimplement hazard mitigation in certain aspects. For example, theprocessor 1900 may be programmed to monitor various aspects of userinput and/or other inputs (e.g., touch screen inputs 2150, foot switch1430 inputs, temperature sensor inputs 2160) and may disable the driveoutput of the generator 1100 when an erroneous condition is detected.

In certain aspects, both the processor 1740 (FIG. 23, 24A) and theprocessor 1900 (FIG. 23, 24B) may determine and monitor the operatingstate of the generator 1100. For processor 1740, the operating state ofthe generator 1100 may dictate, for example, which control and/ordiagnostic processes are implemented by the processor 1740. Forprocessor 1900, the operating state of the generator 1100 may dictate,for example, which elements of a user interface (e.g., display screens,sounds) are presented to a user. The processors 1740, 1900 mayindependently maintain the current operating state of the generator 1100and recognize and evaluate possible transitions out of the currentoperating state. The processor 1740 may function as the master in thisrelationship and determine when transitions between operating states areto occur. The processor 1900 may be aware of valid transitions betweenoperating states and may confirm if a particular transition isappropriate. For example, when the processor 1740 instructs theprocessor 1900 to transition to a specific state, the processor 1900 mayverify that the requested transition is valid. In the event that arequested transition between states is determined to be invalid by theprocessor 1900, the processor 1900 may cause the generator 1100 to entera failure mode.

The non-isolated stage 1540 may further comprise a controller 1960 (FIG.23, 24B) for monitoring input devices 2150 (e.g., a capacitive touchsensor used for turning the generator 1100 on and off, a capacitivetouch screen). In certain aspects, the controller 1960 may comprise atleast one processor and/or other controller device in communication withthe processor 1900. In one aspect, for example, the controller 1960 maycomprise a processor (e.g., a Mega168 8-bit controller available fromAtmel) configured to monitor user input provided via one or morecapacitive touch sensors. In one aspect, the controller 1960 maycomprise a touch screen controller (e.g., a QT5480 touch screencontroller available from Atmel) to control and manage the acquisitionof touch data from a capacitive touch screen.

In certain aspects, when the generator 1100 is in a “power off” state,the controller 1960 may continue to receive operating power (e.g., via aline from a power supply of the generator 1100, such as the power supply2110 (FIG. 23) discussed below). In this way, the controller 1960 maycontinue to monitor an input device 2150 (e.g., a capacitive touchsensor located on a front panel of the generator 1100) for turning thegenerator 1100 on and off. When the generator 1100 is in the “power off”state, the controller 1960 may wake the power supply (e.g., enableoperation of one or more DC/DC voltage converters 2130 (FIG. 23) of thepower supply 2110) if activation of the “on/off” input device 2150 by auser is detected. The controller 1960 may therefore initiate a sequencefor transitioning the generator 1100 to a “power on” state. Conversely,the controller 1960 may initiate a sequence for transitioning thegenerator 1100 to the “power off” state if activation of the “on/off”input device 2150 is detected when the generator 1100 is in the “poweron” state. In certain aspects, for example, the controller 1960 mayreport activation of the “on/off” input device 2150 to the processor1900, which in turn implements the necessary process sequence fortransitioning the generator 1100 to the “power off” state. In suchaspects, the controller 1960 may have no independent ability for causingthe removal of power from the generator 1100 after its “power on” statehas been established.

In certain aspects, the controller 1960 may cause the generator 1100 toprovide audible or other sensory feedback for alerting the user that a“power on” or “power off” sequence has been initiated. Such an alert maybe provided at the beginning of a “power on” or “power off” sequence andprior to the commencement of other processes associated with thesequence.

In certain aspects, the isolated stage 1520 may comprise an instrumentinterface circuit 1980 to, for example, provide a communicationinterface between a control circuit of a surgical device (e.g., acontrol circuit comprising handpiece switches) and components of thenon-isolated stage 1540, such as, for example, the programmable logicdevice 1660, the processor 1740 and/or the processor 1900. Theinstrument interface circuit 1980 may exchange information withcomponents of the non-isolated stage 1540 via a communication link thatmaintains a suitable degree of electrical isolation between the stages1520, 1540, such as, for example, an infrared (IR)-based communicationlink. Power may be supplied to the instrument interface circuit 1980using, for example, a low-dropout voltage regulator powered by anisolation transformer driven from the non-isolated stage 1540.

In one aspect, the instrument interface circuit 1980 may comprise aprogrammable logic device 2000 (e.g., an FPGA) in communication with asignal conditioning circuit 2020 (FIG. 23 and FIG. 24C). The signalconditioning circuit 2020 may be configured to receive a periodic signalfrom the programmable logic device 2000 (e.g., a 2 kHz square wave) togenerate a bipolar interrogation signal having an identical frequency.The interrogation signal may be generated, for example, using a bipolarcurrent source fed by a differential amplifier. The interrogation signalmay be communicated to a surgical device control circuit (e.g., by usinga conductive pair in a cable that connects the generator 1100 to thesurgical device) and monitored to determine a state or configuration ofthe control circuit. For example, the control circuit may comprise anumber of switches, resistors and/or diodes to modify one or morecharacteristics (e.g., amplitude, rectification) of the interrogationsignal such that a state or configuration of the control circuit isuniquely discernible based on the one or more characteristics. In oneaspect, for example, the signal conditioning circuit 2020 may comprisean ADC for generating samples of a voltage signal appearing acrossinputs of the control circuit resulting from passage of interrogationsignal therethrough. The programmable logic device 2000 (or a componentof the non-isolated stage 1540) may then determine the state orconfiguration of the control circuit based on the ADC samples.

In one aspect, the instrument interface circuit 1980 may comprise afirst data circuit interface 2040 to enable information exchange betweenthe programmable logic device 2000 (or other element of the instrumentinterface circuit 1980) and a first data circuit disposed in orotherwise associated with a surgical device. In certain aspects, forexample, a first data circuit 2060 may be disposed in a cable integrallyattached to a surgical device handpiece, or in an adaptor forinterfacing a specific surgical device type or model with the generator1100. In certain aspects, the first data circuit may comprise anon-volatile storage device, such as an electrically erasableprogrammable read-only memory (EEPROM) device. In certain aspects andreferring again to FIG. 23, the first data circuit interface 2040 may beimplemented separately from the programmable logic device 2000 andcomprise suitable circuitry (e.g., discrete logic devices, a processor)to enable communication between the programmable logic device 2000 andthe first data circuit. In other aspects, the first data circuitinterface 2040 may be integral with the programmable logic device 2000.

In certain aspects, the first data circuit 2060 may store informationpertaining to the particular surgical device with which it isassociated. Such information may include, for example, a model number, aserial number, a number of operations in which the surgical device hasbeen used, and/or any other type of information. This information may beread by the instrument interface circuit 1980 (e.g., by the programmablelogic device 2000), transferred to a component of the non-isolated stage1540 (e.g., to programmable logic device 1660, processor 1740 and/orprocessor 1900) for presentation to a user via an output device 2140and/or for controlling a function or operation of the generator 1100.Additionally, any type of information may be communicated to first datacircuit 2060 for storage therein via the first data circuit interface2040 (e.g., using the programmable logic device 2000). Such informationmay comprise, for example, an updated number of operations in which thesurgical device has been used and/or dates and/or times of its usage.

As discussed previously, a surgical instrument may be detachable from ahandpiece (e.g., instrument 1106 may be detachable from handpiece 1107)to promote instrument interchangeability and/or disposability. In suchcases, known generators may be limited in their ability to recognizeparticular instrument configurations being used and to optimize controland diagnostic processes accordingly. The addition of readable datacircuits to surgical device instruments to address this issue isproblematic from a compatibility standpoint, however. For example, itmay be impractical to design a surgical device to maintain backwardcompatibility with generators that lack the requisite data readingfunctionality due to, for example, differing signal schemes, designcomplexity and cost. Other aspects of instruments address these concernsby using data circuits that may be implemented in existing surgicalinstruments economically and with minimal design changes to preservecompatibility of the surgical devices with current generator platforms.

Additionally, aspects of the generator 1100 may enable communicationwith instrument-based data circuits. For example, the generator 1100 maybe configured to communicate with a second data circuit (e.g., a datacircuit) contained in an instrument (e.g., instrument 1104, 1106 or1108) of a surgical device. The instrument interface circuit 1980 maycomprise a second data circuit interface 2100 to enable thiscommunication. In one aspect, the second data circuit interface 2100 maycomprise a tri-state digital interface, although other interfaces mayalso be used. In certain aspects, the second data circuit may generallybe any circuit for transmitting and/or receiving data. In one aspect,for example, the second data circuit may store information pertaining tothe particular surgical instrument with which it is associated. Suchinformation may include, for example, a model number, a serial number, anumber of operations in which the surgical instrument has been used,and/or any other type of information. Additionally or alternatively, anytype of information may be communicated to the second data circuit forstorage therein via the second data circuit interface 2100 (e.g., usingthe programmable logic device 2000). Such information may comprise, forexample, an updated number of operations in which the instrument hasbeen used and/or dates and/or times of its usage. In certain aspects,the second data circuit may transmit data acquired by one or moresensors (e.g., an instrument-based temperature sensor). In certainaspects, the second data circuit may receive data from the generator1100 and provide an indication to a user (e.g., an LED indication orother visible indication) based on the received data.

In certain aspects, the second data circuit and the second data circuitinterface 2100 may be configured such that communication between theprogrammable logic device 2000 and the second data circuit can beeffected without the need to provide additional conductors for thispurpose (e.g., dedicated conductors of a cable connecting a handpiece tothe generator 1100). In one aspect, for example, information may becommunicated to and from the second data circuit using a one-wire buscommunication scheme implemented on existing cabling, such as one of theconductors used transmit interrogation signals from the signalconditioning circuit 2020 to a control circuit in a handpiece. In thisway, design changes or modifications to the surgical device that mightotherwise be necessary are minimized or reduced. Moreover, becausedifferent types of communications can be implemented over a commonphysical channel (either with or without frequency-band separation), thepresence of a second data circuit may be “invisible” to generators thatdo not have the requisite data reading functionality, thus enablingbackward compatibility of the surgical device instrument.

In certain aspects, the isolated stage 1520 may comprise at least oneblocking capacitor 2960-1 (FIG. 24C) connected to the drive signaloutput 1600 b to prevent passage of DC current to a patient. A singleblocking capacitor may be required to comply with medical regulations orstandards, for example. While failure in single-capacitor designs isrelatively uncommon, such failure may nonetheless have negativeconsequences. In one aspect, a second blocking capacitor 2960-2 may beprovided in series with the blocking capacitor 2960-1, with currentleakage from a point between the blocking capacitors 2960-1, 2960-2being monitored by, for example, an ADC 2980 for sampling a voltageinduced by leakage current. The samples may be received by theprogrammable logic device 2000, for example. Based on changes in theleakage current (as indicated by the voltage samples in the aspect ofFIG. 23), the generator 1100 may determine when at least one of theblocking capacitors 2960-1, 2960-2 has failed. Accordingly, the aspectof FIG. 23 may provide a benefit over single-capacitor designs having asingle point of failure.

In certain aspects, the non-isolated stage 1540 may comprise a powersupply 2110 for outputting DC power at a suitable voltage and current.The power supply may comprise, for example, a 400 W power supply foroutputting a 48 VDC system voltage. As discussed above, the power supply2110 may further comprise one or more DC/DC voltage converters 2130 forreceiving the output of the power supply to generate DC outputs at thevoltages and currents required by the various components of thegenerator 1100. As discussed above in connection with the controller1960, one or more of the DC/DC voltage converters 2130 may receive aninput from the controller 1960 when activation of the “on/off” inputdevice 2150 by a user is detected by the controller 1960 to enableoperation of, or wake, the DC/DC voltage converters 2130.

FIGS. 25A-25B illustrate certain functional and structural aspects ofone aspect of the generator 1100. Feedback indicating current andvoltage output from the secondary winding 1580 of the power transformer1560 is received by the ADCs 1780, 1800, respectively. As shown, theADCs 1780, 1800 may be implemented as a 2-channel ADC and may sample thefeedback signals at a high speed (e.g., 80 Msps) to enable oversampling(e.g., approximately 200× oversampling) of the drive signals. Thecurrent and voltage feedback signals may be suitably conditioned in theanalog domain (e.g., amplified, filtered) prior to processing by theADCs 1780, 1800. Current and voltage feedback samples from the ADCs1780, 1800 may be individually buffered and subsequently multiplexed orinterleaved into a single data stream within block 2120 of theprogrammable logic device 1660. In the aspect of FIGS. 25A-25B, theprogrammable logic device 1660 comprises an FPGA.

The multiplexed current and voltage feedback samples may be received bya parallel data acquisition port (PDAP) implemented within block 2144 ofthe processor 1740. The PDAP may comprise a packing unit forimplementing any of a number of methodologies for correlating themultiplexed feedback samples with a memory address. In one aspect, forexample, feedback samples corresponding to a particular LUT sampleoutput by the programmable logic device 1660 may be stored at one ormore memory addresses that are correlated or indexed with the LUTaddress of the LUT sample. In another aspect, feedback samplescorresponding to a particular LUT sample output by the programmablelogic device 1660 may be stored, along with the LUT address of the LUTsample, at a common memory location. In any event, the feedback samplesmay be stored such that the address of the LUT sample from which aparticular set of feedback samples originated may be subsequentlyascertained. As discussed above, synchronization of the LUT sampleaddresses and the feedback samples in this way contributes to thecorrect timing and stability of the pre-distortion algorithm. A directmemory access (DMA) controller implemented at block 2166 of theprocessor 1740 may store the feedback samples (and any LUT sampleaddress data, where applicable) at a designated memory location 2180 ofthe processor 1740 (e.g., internal RAM).

Block 2200 of the processor 1740 may implement a pre-distortionalgorithm for pre-distorting or modifying the LUT samples stored in theprogrammable logic device 1660 on a dynamic, ongoing basis. As discussedabove, pre-distortion of the LUT samples may compensate for varioussources of distortion present in the output drive circuit of thegenerator 1100. The pre-distorted LUT samples, when processed throughthe drive circuit, will therefore result in a drive signal having thedesired waveform shape (e.g., sinusoidal) for optimally driving theultrasonic transducer.

At block 2220 of the pre-distortion algorithm, the current through themotional branch of the ultrasonic transducer is determined. The motionalbranch current may be determined using Kirchhoff's Current Law based on,for example, the current and voltage feedback samples stored at memorylocation 2180 (which, when suitably scaled, may be representative ofI_(g) and V_(g) in the model of FIG. 22 discussed above), a value of theultrasonic transducer static capacitance C₀ (measured or known a priori)and a known value of the drive frequency. A motional branch currentsample for each set of stored current and voltage feedback samplesassociated with a LUT sample may be determined.

At block 2240 of the pre-distortion algorithm, each motional branchcurrent sample determined at block 2220 is compared to a sample of adesired current waveform shape to determine a difference, or sampleamplitude error, between the compared samples. For this determination,the sample of the desired current waveform shape may be supplied, forexample, from a waveform shape LUT 2260 containing amplitude samples forone cycle of a desired current waveform shape. The particular sample ofthe desired current waveform shape from the LUT 2260 used for thecomparison may be dictated by the LUT sample address associated with themotional branch current sample used in the comparison. Accordingly, theinput of the motional branch current to block 2240 may be synchronizedwith the input of its associated LUT sample address to block 2240. TheLUT samples stored in the programmable logic device 1660 and the LUTsamples stored in the waveform shape LUT 2260 may therefore be equal innumber. In certain aspects, the desired current waveform shaperepresented by the LUT samples stored in the waveform shape LUT 2260 maybe a fundamental sine wave. Other waveform shapes may be desirable. Forexample, it is contemplated that a fundamental sine wave for drivingmain longitudinal motion of an ultrasonic transducer superimposed withone or more other drive signals at other frequencies, such as a thirdorder harmonic for driving at least two mechanical resonances forbeneficial vibrations of transverse or other modes, could be used.

Each value of the sample amplitude error determined at block 2240 may betransmitted to the LUT of the programmable logic device 1660 (shown atblock 2280 in FIG. 25A) along with an indication of its associated LUTaddress. Based on the value of the sample amplitude error and itsassociated address (and, optionally, values of sample amplitude errorfor the same LUT address previously received), the LUT 2280 (or othercontrol block of the programmable logic device 1660) may pre-distort ormodify the value of the LUT sample stored at the LUT address such thatthe sample amplitude error is reduced or minimized. It will beappreciated that such pre-distortion or modification of each LUT samplein an iterative manner across the entire range of LUT addresses willcause the waveform shape of the generator's output current to match orconform to the desired current waveform shape represented by the samplesof the waveform shape LUT 2260.

Current and voltage amplitude measurements, power measurements andimpedance measurements may be determined at block 2300 of the processor1740 based on the current and voltage feedback samples stored at memorylocation 2180. Prior to the determination of these quantities, thefeedback samples may be suitably scaled and, in certain aspects,processed through a suitable filter 2320 to remove noise resulting from,for example, the data acquisition process and induced harmoniccomponents. The filtered voltage and current samples may thereforesubstantially represent the fundamental frequency of the generator'sdrive output signal. In certain aspects, the filter 2320 may be a finiteimpulse response (FIR) filter applied in the frequency domain. Suchaspects may use the Fast Fourier Transform (FFT) of the output drivesignal current and voltage signals. In certain aspects, the resultingfrequency spectrum may be used to provide additional generatorfunctionality. In one aspect, for example, the ratio of the secondand/or third order harmonic component relative to the fundamentalfrequency component may be used as a diagnostic indicator.

At block 2340 (FIG. 25B), a root mean square (RMS) calculation may beapplied to a sample size of the current feedback samples representing anintegral number of cycles of the drive signal to generate a measurementI_(rms) representing the drive signal output current.

At block 2360, a root mean square (RMS) calculation may be applied to asample size of the voltage feedback samples representing an integralnumber of cycles of the drive signal to determine a measurement V_(rms)representing the drive signal output voltage.

At block 2380, the current and voltage feedback samples may bemultiplied point by point, and a mean calculation is applied to samplesrepresenting an integral number of cycles of the drive signal todetermine a measurement P_(r) of the generator's real output power.

At block 2400, measurement P_(a) of the generator's apparent outputpower may be determined as the product V_(rms)·I_(rms).

At block 2420, measurement Z_(m) of the load impedance magnitude may bedetermined as the quotient V_(rms)/I_(rms).

In certain aspects, the quantities I_(rms), V_(rms), P_(r), P_(a) andZ_(m) determined at blocks 2340, 2360, 2380, 2400 and 2420 may be usedby the generator 1100 to implement any of a number of control and/ordiagnostic processes. In certain aspects, any of these quantities may becommunicated to a user via, for example, an output device 2140 integralwith the generator 1100 or an output device 2140 connected to thegenerator 1100 through a suitable communication interface (e.g., a USBinterface). Various diagnostic processes may include, withoutlimitation, handpiece integrity, instrument integrity, instrumentattachment integrity, instrument overload, approaching instrumentoverload, frequency lock failure, over-voltage condition, over-currentcondition, over-power condition, voltage sense failure, current sensefailure, audio indication failure, visual indication failure, shortcircuit condition, power delivery failure, or blocking capacitorfailure, for example.

Block 2440 of the processor 1740 may implement a phase control algorithmfor determining and controlling the impedance phase of an electricalload (e.g., the ultrasonic transducer) driven by the generator 1100. Asdiscussed above, by controlling the frequency of the drive signal tominimize or reduce the difference between the determined impedance phaseand an impedance phase setpoint (e.g., 0°), the effects of harmonicdistortion may be minimized or reduced, and the accuracy of the phasemeasurement increased.

The phase control algorithm receives as input the current and voltagefeedback samples stored in the memory location 2180. Prior to their usein the phase control algorithm, the feedback samples may be suitablyscaled and, in certain aspects, processed through a suitable filter 2460(which may be identical to filter 2320) to remove noise resulting fromthe data acquisition process and induced harmonic components, forexample. The filtered voltage and current samples may thereforesubstantially represent the fundamental frequency of the generator'sdrive output signal.

At block 2480 of the phase control algorithm, the current through themotional branch of the ultrasonic transducer is determined. Thisdetermination may be identical to that described above in connectionwith block 2220 of the pre-distortion algorithm. The output of block2480 may thus be, for each set of stored current and voltage feedbacksamples associated with a LUT sample, a motional branch current sample.

At block 2500 of the phase control algorithm, impedance phase isdetermined based on the synchronized input of motional branch currentsamples determined at block 2480 and corresponding voltage feedbacksamples. In certain aspects, the impedance phase is determined as theaverage of the impedance phase measured at the rising edge of thewaveforms and the impedance phase measured at the falling edge of thewaveforms.

At block 2520 of the of the phase control algorithm, the value of theimpedance phase determined at block 2220 is compared to phase setpoint2540 to determine a difference, or phase error, between the comparedvalues.

At block 2560 (FIG. 25A) of the phase control algorithm, based on avalue of phase error determined at block 2520 and the impedancemagnitude determined at block 2420, a frequency output for controllingthe frequency of the drive signal is determined. The value of thefrequency output may be continuously adjusted by the block 2560 andtransferred to a DDS control block 2680 (discussed below) in order tomaintain the impedance phase determined at block 2500 at the phasesetpoint (e.g., zero phase error). In certain aspects, the impedancephase may be regulated to a 0° phase setpoint. In this way, any harmonicdistortion will be centered about the crest of the voltage waveform,enhancing the accuracy of phase impedance determination.

Block 2580 of the processor 1740 may implement an algorithm formodulating the current amplitude of the drive signal in order to controlthe drive signal current, voltage and power in accordance with userspecified setpoints, or in accordance with requirements specified byother processes or algorithms implemented by the generator 1100. Controlof these quantities may be realized, for example, by scaling the LUTsamples in the LUT 2280 and/or by adjusting the full-scale outputvoltage of the DAC 1680 (which supplies the input to the power amplifier1620) via a DAC 1860. Block 2600 (which may be implemented as a PIDcontroller in certain aspects) may receive, as input, current feedbacksamples (which may be suitably scaled and filtered) from the memorylocation 2180. The current feedback samples may be compared to a“current demand” I_(d) value dictated by the controlled variable (e.g.,current, voltage or power) to determine if the drive signal is supplyingthe necessary current. In aspects in which drive signal current is thecontrol variable, the current demand I_(d) may be specified directly bya current setpoint 2620A (I_(sp)). For example, an RMS value of thecurrent feedback data (determined as in block 2340) may be compared touser-specified RMS current setpoint I_(sp) to determine the appropriatecontroller action. If, for example, the current feedback data indicatesan RMS value less than the current setpoint I_(SP), LUT scaling and/orthe full-scale output voltage of the DAC 1680 may be adjusted by theblock 2600 such that the drive signal current is increased. Conversely,block 2600 may adjust LUT scaling and/or the full-scale output voltageof the DAC 1680 to decrease the drive signal current when the currentfeedback data indicates an RMS value greater than the current setpointI_(sp).

In aspects in which the drive signal voltage is the control variable,the current demand I_(d) may be specified indirectly, for example, basedon the current required to maintain a desired voltage setpoint 2620B(V_(sp)) given the load impedance magnitude Z_(m) measured at block 2420(e.g. I_(d)=V_(sp)/Z_(m)). Similarly, in aspects in which drive signalpower is the control variable, the current demand I_(d) may be specifiedindirectly, for example, based on the current required to maintain adesired power setpoint 2620C (P_(sp)) given the voltage V_(rms) measuredat blocks 2360 (e.g. I_(d)=P_(sp)/V_(rms)).

Block 2680 (FIG. 25A) may implement a DDS control algorithm forcontrolling the drive signal by recalling LUT samples stored in the LUT2280. In certain aspects, the DDS control algorithm may be anumerically-controlled oscillator (NCO) algorithm for generating samplesof a waveform at a fixed clock rate using a point (memorylocation)-skipping technique. The NCO algorithm may implement a phaseaccumulator, or frequency-to-phase converter, that functions as anaddress pointer for recalling LUT samples from the LUT 2280. In oneaspect, the phase accumulator may be a D step size, modulo N phaseaccumulator, where D is a positive integer representing a frequencycontrol value, and N is the number of LUT samples in the LUT 2280. Afrequency control value of D=1, for example, may cause the phaseaccumulator to sequentially point to every address of the LUT 2280,resulting in a waveform output replicating the waveform stored in theLUT 2280. When D>1, the phase accumulator may skip addresses in the LUT2280, resulting in a waveform output having a higher frequency.Accordingly, the frequency of the waveform generated by the DDS controlalgorithm may therefore be controlled by suitably varying the frequencycontrol value. In certain aspects, the frequency control value may bedetermined based on the output of the phase control algorithmimplemented at block 2440. The output of block 2680 may supply the inputof DAC 1680, which in turn supplies a corresponding analog signal to aninput of the power amplifier 1620.

Block 2700 of the processor 1740 may implement a switch-mode convertercontrol algorithm for dynamically modulating the rail voltage of thepower amplifier 1620 based on the waveform envelope of the signal beingamplified, thereby improving the efficiency of the power amplifier 1620.In certain aspects, characteristics of the waveform envelope may bedetermined by monitoring one or more signals contained in the poweramplifier 1620. In one aspect, for example, characteristics of thewaveform envelope may be determined by monitoring the minima of a drainvoltage (e.g., a MOSFET drain voltage) that is modulated in accordancewith the envelope of the amplified signal. A minima voltage signal maybe generated, for example, by a voltage minima detector coupled to thedrain voltage. The minima voltage signal may be sampled by ADC 1760,with the output minima voltage samples being received at block 2720 ofthe switch-mode converter control algorithm. Based on the values of theminima voltage samples, block 2740 may control a PWM signal output by aPWM generator 2760, which, in turn, controls the rail voltage suppliedto the power amplifier 1620 by the switch-mode regulator 1700. Incertain aspects, as long as the values of the minima voltage samples areless than a minima target 2780 input into block 2720, the rail voltagemay be modulated in accordance with the waveform envelope ascharacterized by the minima voltage samples. When the minima voltagesamples indicate low envelope power levels, for example, block 2740 maycause a low rail voltage to be supplied to the power amplifier 1620,with the full rail voltage being supplied only when the minima voltagesamples indicate maximum envelope power levels. When the minima voltagesamples fall below the minima target 2780, block 2740 may cause the railvoltage to be maintained at a minimum value suitable for ensuring properoperation of the power amplifier 1620.

FIG. 26 is a schematic diagram of one aspect of an electrical circuit2900, suitable for driving an ultrasonic transducer, such as ultrasonictransducer 1120, in accordance with at least one aspect of the presentdisclosure. The electrical circuit 2900 comprises an analog multiplexer2980. The analog multiplexer 2980 multiplexes various signals from theupstream channels SCL-A, SDA-A such as ultrasonic, battery, and powercontrol circuit. A current sensor 2982 is coupled in series with thereturn or ground leg of the power supply circuit to measure the currentsupplied by the power supply. A field effect transistor (FET)temperature sensor 2984 provides the ambient temperature. A pulse widthmodulation (PWM) watchdog timer 2988 automatically generates a systemreset if the main program neglects to periodically service it. It isprovided to automatically reset the electrical circuit 2900 when ithangs or freezes because of a software or hardware fault. It will beappreciated that the electrical circuit 2900 may be configured as an RFdriver circuit for driving the ultrasonic transducer or for driving RFelectrodes such as the electrical circuit 3600 shown in FIG. 31, forexample. Accordingly, with reference now back to FIG. 26, the electricalcircuit 2900 can be used to drive both ultrasonic transducers and RFelectrodes interchangeably. If driven simultaneously, filter circuitsmay be provided in the corresponding first stage circuits 3404 (FIG. 29)to select either the ultrasonic waveform or the RF waveform. Suchfiltering techniques are described in commonly owned U.S. Pat. Pub. No.US-2017-0086910-A1, titled TECHNIQUES FOR CIRCUIT TOPOLOGIES FORCOMBINED GENERATOR, which is herein incorporated by reference in itsentirety.

A drive circuit 2986 provides left and right ultrasonic energy outputs.A digital signal that represents the signal waveform is provided to theSCL-A, SDA-A inputs of the analog multiplexer 2980 from a controlcircuit, such as the control circuit 3200 (FIG. 27). A digital-to-analogconverter 2990 (DAC) converts the digital input to an analog output todrive a PWM circuit 2992 coupled to an oscillator 2994. The PWM circuit2992 provides a first signal to a first gate drive circuit 2996 acoupled to a first transistor output stage 2998 a to drive a firstUltrasonic (LEFT) energy output. The PWM circuit 2992 also provides asecond signal to a second gate drive circuit 2996 b coupled to a secondtransistor output stage 2998 b to drive a second Ultrasonic (RIGHT)energy output. A voltage sensor 2999 is coupled between the UltrasonicLEFT/RIGHT output terminals to measure the output voltage. The drivecircuit 2986, the first and second drive circuits 2996 a, 2996 b, andthe first and second transistor output stages 2998 a, 2998 b define afirst stage amplifier circuit. In operation, the control circuit 3200(FIG. 27) generates a digital waveform 4300 (FIG. 36) employing circuitssuch as direct digital synthesis (DDS) circuits 4100, 4200 (FIGS. 41 and42). The DAC 2990 receives the digital waveform 4300 and converts itinto an analog waveform, which is received and amplified by the firststage amplifier circuit.

FIG. 27 is a schematic diagram of a control circuit 3200, such ascontrol circuit 3212, in accordance with at least one aspect of thepresent disclosure. The control circuit 3200 is located within a housingof the battery assembly. The battery assembly is the energy source for avariety of local power supplies 3215. The control circuit comprises amain processor 3214 coupled via an interface master 3218 to variousdownstream circuits by way of outputs SCL-A and SDA-A, SCL-B and SDA-B,SCL-C and SDA-C, for example. In one aspect, the interface master 3218is a general purpose serial interface such as an I²C serial interface.The main processor 3214 also is configured to drive switches 3224through general purposes input/output (GPIO) 3220, a display 3226 (e.g.,and LCD display), and various indicators 3228 through GPIO 3222. Awatchdog processor 3216 is provided to control the main processor 3214.A switch 3230 is provided in series with a battery 3211 to activate thecontrol circuit 3212 upon insertion of the battery assembly into ahandle assembly of a surgical instrument.

In one aspect, the main processor 3214 is coupled to the electricalcircuit 2900 (FIG. 26) by way of output terminals SCL-A, SDA-A. The mainprocessor 3214 comprises a memory for storing tables of digitized drivesignals or waveforms that are transmitted to the electrical circuit 2900for driving the ultrasonic transducer 1120, for example. In otheraspects, the main processor 3214 may generate a digital waveform andtransmit it to the electrical circuit 2900 or may store the digitalwaveform for later transmission to the electrical circuit 2900. The mainprocessor 3214 also may provide RF drive by way of output terminalsSCL-B, SDA-B and various sensors (e.g., Hall-effect sensors,magneto-rheological fluid (MRF) sensors, etc.) by way of outputterminals SCL-C, SDA-C. In one aspect, the main processor 3214 isconfigured to sense the presence of ultrasonic drive circuitry and/or RFdrive circuitry to enable appropriate software and user interfacefunctionality.

In one aspect, the main processor 3214 may be an LM 4F230H5QR, availablefrom Texas Instruments, for example. In at least one example, the TexasInstruments LM4F230H5QR is an ARM Cortex-M4F Processor Core comprisingon-chip memory of 256 KB single-cycle flash memory, or othernon-volatile memory, up to 40 MHz, a prefetch buffer to improveperformance above 40 MHz, a 32 KB single-cycle serial random accessmemory (SRAM), internal read-only memory (ROM) loaded withStellarisWare® software, 2 KB electrically erasable programmableread-only memory (EEPROM), one or more pulse width modulation (PWM)modules, one or more quadrature encoder inputs (QED analog, one or more12-bit Analog-to-Digital Converters (ADC) with 12 analog input channels,among other features that are readily available from the productdatasheet. Other processors may be readily substituted and, accordingly,the present disclosure should not be limited in this context.

FIG. 28 shows a simplified block circuit diagram illustrating anotherelectrical circuit 3300 contained within a modular ultrasonic surgicalinstrument 3334, in accordance with at least one aspect of the presentdisclosure. The electrical circuit 3300 includes a processor 3302, aclock 3330, a memory 3326, a power supply 3304 (e.g., a battery), aswitch 3306, such as a metal-oxide semiconductor field effect transistor(MOSFET) power switch, a drive circuit 3308 (PLL), a transformer 3310, asignal smoothing circuit 3312 (also referred to as a matching circuitand can be, for example, a tank circuit), a sensing circuit 3314, atransducer 1120, and a shaft assembly (e.g. shaft assembly 1126, 1129)comprising an ultrasonic transmission waveguide that terminates at anultrasonic blade (e.g. ultrasonic blade 1128, 1149) which may bereferred to herein simply as the waveguide.

One feature of the present disclosure that severs dependency on highvoltage (120 VAC) input power (a characteristic of general ultrasoniccutting devices) is the utilization of low-voltage switching throughoutthe wave-forming process and the amplification of the driving signalonly directly before the transformer stage. For this reason, in oneaspect of the present disclosure, power is derived from only a battery,or a group of batteries, small enough to fit either within a handleassembly. State-of-the-art battery technology provides powerfulbatteries of a few centimeters in height and width and a few millimetersin depth. By combining the features of the present disclosure to providea self-contained and self-powered ultrasonic device, a reduction inmanufacturing cost may be achieved.

The output of the power supply 3304 is fed to and powers the processor3302. The processor 3302 receives and outputs signals and, as will bedescribed below, functions according to custom logic or in accordancewith computer programs that are executed by the processor 3302. Asdiscussed above, the electrical circuit 3300 can also include a memory3326, preferably, random access memory (RAM), that storescomputer-readable instructions and data.

The output of the power supply 3304 also is directed to the switch 3306having a duty cycle controlled by the processor 3302. By controlling theon-time for the switch 3306, the processor 3302 is able to dictate thetotal amount of power that is ultimately delivered to the transducer1120. In one aspect, the switch 3306 is a MOSFET, although otherswitches and switching configurations are adaptable as well. The outputof the switch 3306 is fed to a drive circuit 3308 that contains, forexample, a phase detecting phase-locked loop (PLL) and/or a low-passfilter and/or a voltage-controlled oscillator. The output of the switch3306 is sampled by the processor 3302 to determine the voltage andcurrent of the output signal (V_(IN) and I_(IN), respectively). Thesevalues are used in a feedback architecture to adjust the pulse widthmodulation of the switch 3306. For instance, the duty cycle of theswitch 3306 can vary from about 20% to about 80%, depending on thedesired and actual output from the switch 3306.

The drive circuit 3308, which receives the signal from the switch 3306,includes an oscillatory circuit that turns the output of the switch 3306into an electrical signal having an ultrasonic frequency, e.g., 55 kHz(VCO). As explained above, a smoothed-out version of this ultrasonicwaveform is ultimately fed to the ultrasonic transducer 1120 to producea resonant sine wave along an ultrasonic transmission waveguide.

At the output of the drive circuit 3308 is a transformer 3310 that isable to step up the low voltage signal(s) to a higher voltage. It isnoted that upstream switching, prior to the transformer 3310, isperformed at low (e.g., battery driven) voltages, something that, todate, has not been possible for ultrasonic cutting and cautery devices.This is at least partially due to the fact that the deviceadvantageously uses low on-resistance MOSFET switching devices. Lowon-resistance MOSFET switches are advantageous, as they produce lowerswitching losses and less heat than a traditional MOSFET device andallow higher current to pass through. Therefore, the switching stage(pre-transformer) can be characterized as low voltage/high current. Toensure the lower on-resistance of the amplifier MOSFET(s), the MOSFET(s)are run, for example, at 10 V. In such a case, a separate 10 VDC powersupply can be used to feed the MOSFET gate, which ensures that theMOSFET is fully on and a reasonably low on resistance is achieved. Inone aspect of the present disclosure, the transformer 3310 steps up thebattery voltage to 120 V root-mean-square (RMS). Transformers are knownin the art and are, therefore, not explained here in detail.

In the circuit configurations described, circuit component degradationcan negatively impact the circuit performance of the circuit. One factorthat directly affects component performance is heat. Known circuitsgenerally monitor switching temperatures (e.g., MOSFET temperatures).However, because of the technological advancements in MOSFET designs,and the corresponding reduction in size, MOSFET temperatures are nolonger a valid indicator of circuit loads and heat. For this reason, inaccordance with at least one aspect of the present disclosure, thesensing circuit 3314 senses the temperature of the transformer 3310.This temperature sensing is advantageous as the transformer 3310 is runat or very close to its maximum temperature during use of the device.Additional temperature will cause the core material, e.g., the ferrite,to break down and permanent damage can occur. The present disclosure canrespond to a maximum temperature of the transformer 3310 by, forexample, reducing the driving power in the transformer 3310, signalingthe user, turning the power off, pulsing the power, or other appropriateresponses.

In one aspect of the present disclosure, the processor 3302 iscommunicatively coupled to the end effector (e.g. 1122, 1125), which isused to place material in physical contact with the ultrasonic blade(e.g. 1128, 1149). Sensors are provided that measure, at the endeffector, a clamping force value (existing within a known range) and,based upon the received clamping force value, the processor 3302 variesthe motional voltage V_(M). Because high force values combined with aset motional rate can result in high blade temperatures, a temperaturesensor 3332 can be communicatively coupled to the processor 3302, wherethe processor 3302 is operable to receive and interpret a signalindicating a current temperature of the blade from the temperaturesensor 3336 and to determine a target frequency of blade movement basedupon the received temperature. In another aspect, force sensors such asstrain gages or pressure sensors may be coupled to the trigger (e.g.1143, 1147) to measure the force applied to the trigger by the user. Inanother aspect, force sensors such as strain gages or pressure sensorsmay be coupled to a switch button such that displacement intensitycorresponds to the force applied by the user to the switch button.

In accordance with at least one aspect of the present disclosure, thePLL portion of the drive circuit 3308, which is coupled to the processor3302, is able to determine a frequency of waveguide movement andcommunicate that frequency to the processor 3302. The processor 3302stores this frequency value in the memory 3326 when the device is turnedoff. By reading the clock 3330, the processor 3302 is able to determinean elapsed time after the device is shut off and retrieve the lastfrequency of waveguide movement if the elapsed time is less than apredetermined value. The device can then start up at the last frequency,which, presumably, is the optimum frequency for the current load.

Modular Battery Powered Handheld Surgical Instrument with MultistageGenerator Circuits

In another aspect, the present disclosure provides a modular batterypowered handheld surgical instrument with multistage generator circuits.Disclosed is a surgical instrument that includes a battery assembly, ahandle assembly, and a shaft assembly where the battery assembly and theshaft assembly are configured to mechanically and electrically connectto the handle assembly. The battery assembly includes a control circuitconfigured to generate a digital waveform. The handle assembly includesa first stage circuit configured to receive the digital waveform,convert the digital waveform into an analog waveform, and amplify theanalog waveform. The shaft assembly includes a second stage circuitcoupled to the first stage circuit to receive, amplify, and apply theanalog waveform to a load.

In one aspect, the present disclosure provides a surgical instrument,comprising: a battery assembly, comprising a control circuit comprisinga battery, a memory coupled to the battery, and a processor coupled tothe memory and the battery, wherein the processor is configured togenerate a digital waveform; a handle assembly comprising a first stagecircuit coupled to the processor, the first stage circuit comprising adigital-to-analog (DAC) converter and a first stage amplifier circuit,wherein the DAC is configured to receive the digital waveform andconvert the digital waveform into an analog waveform, wherein the firststage amplifier circuit is configured to receive and amplify the analogwaveform; and a shaft assembly comprising a second stage circuit coupledto the first stage amplifier circuit to receive the analog waveform,amplify the analog waveform, and apply the analog waveform to a load;wherein the battery assembly and the shaft assembly are configured tomechanically and electrically connect to the handle assembly.

The load may comprise any one of an ultrasonic transducer, an electrode,or a sensor, or any combinations thereof. The first stage circuit maycomprise a first stage ultrasonic drive circuit and a first stagehigh-frequency current drive circuit. The control circuit may beconfigured to drive the first stage ultrasonic drive circuit and thefirst stage high-frequency current drive circuit independently orsimultaneously. The first stage ultrasonic drive circuit may beconfigured to couple to a second stage ultrasonic drive circuit. Thesecond stage ultrasonic drive circuit may be configured to couple to anultrasonic transducer. The first stage high-frequency current drivecircuit may be configured to couple to a second stage high-frequencydrive circuit. The second stage high-frequency drive circuit may beconfigured to couple to an electrode.

The first stage circuit may comprise a first stage sensor drive circuit.The first stage sensor drive circuit may be configured to a second stagesensor drive circuit. The second stage sensor drive circuit may beconfigured to couple to a sensor.

In another aspect, the present disclosure provides a surgicalinstrument, comprising: a battery assembly, comprising a control circuitcomprising a battery, a memory coupled to the battery, and a processorcoupled to the memory and the battery, wherein the processor isconfigured to generate a digital waveform; a handle assembly comprisinga common first stage circuit coupled to the processor, the common firststage circuit comprising a digital-to-analog (DAC) converter and acommon first stage amplifier circuit, wherein the DAC is configured toreceive the digital waveform and convert the digital waveform into ananalog waveform, wherein the common first stage amplifier circuit isconfigured to receive and amplify the analog waveform; and a shaftassembly comprising a second stage circuit coupled to the common firststage amplifier circuit to receive the analog waveform, amplify theanalog waveform, and apply the analog waveform to a load; wherein thebattery assembly and the shaft assembly are configured to mechanicallyand electrically connect to the handle assembly.

The load may comprise any one of an ultrasonic transducer, an electrode,or a sensor, or any combinations thereof. The common first stage circuitmay be configured to drive ultrasonic, high-frequency current, or sensorcircuits. The common first stage drive circuit may be configured tocouple to a second stage ultrasonic drive circuit, a second stagehigh-frequency drive circuit, or a second stage sensor drive circuit.The second stage ultrasonic drive circuit may be configured to couple toan ultrasonic transducer, the second stage high-frequency drive circuitis configured to couple to an electrode, and the second stage sensordrive circuit is configured to couple to a sensor.

In another aspect, the present disclosure provides a surgicalinstrument, comprising a control circuit comprising a memory coupled toa processor, wherein the processor is configured to generate a digitalwaveform; a handle assembly comprising a common first stage circuitcoupled to the processor, the common first stage circuit configured toreceive the digital waveform, convert the digital waveform into ananalog waveform, and amplify the analog waveform; and a shaft assemblycomprising a second stage circuit coupled to the common first stagecircuit to receive and amplify the analog waveform; wherein the shaftassembly is configured to mechanically and electrically connect to thehandle assembly.

The common first stage circuit may be configured to drive ultrasonic,high-frequency current, or sensor circuits. The common first stage drivecircuit may be configured to couple to a second stage ultrasonic drivecircuit, a second stage high-frequency drive circuit, or a second stagesensor drive circuit. The second stage ultrasonic drive circuit may beconfigured to couple to an ultrasonic transducer, the second stagehigh-frequency drive circuit is configured to couple to an electrode,and the second stage sensor drive circuit is configured to couple to asensor.

FIG. 29 illustrates a generator circuit 3400 partitioned into a firststage circuit 3404 and a second stage circuit 3406, in accordance withat least one aspect of the present disclosure. In one aspect, thesurgical instruments of surgical system 1000 described herein maycomprise a generator circuit 3400 partitioned into multiple stages. Forexample, surgical instruments of surgical system 1000 may comprise thegenerator circuit 3400 partitioned into at least two circuits: the firststage circuit 3404 and the second stage circuit 3406 of amplificationenabling operation of RF energy only, ultrasonic energy only, and/or acombination of RF energy and ultrasonic energy. A combination modularshaft assembly 3414 may be powered by the common first stage circuit3404 located within a handle assembly 3412 and the modular second stagecircuit 3406 integral to the modular shaft assembly 3414. As previouslydiscussed throughout this description in connection with the surgicalinstruments of surgical system 1000, a battery assembly 3410 and theshaft assembly 3414 are configured to mechanically and electricallyconnect to the handle assembly 3412. The end effector assembly isconfigured to mechanically and electrically connect the shaft assembly3414.

Turning now to FIG. 29, the generator circuit 3400 is partitioned intomultiple stages located in multiple modular assemblies of a surgicalinstrument, such as the surgical instruments of surgical system 1000described herein. In one aspect, a control stage circuit 3402 may belocated in the battery assembly 3410 of the surgical instrument. Thecontrol stage circuit 3402 is a control circuit 3200 as described inconnection with FIG. 27. The control circuit 3200 comprises a processor3214, which includes internal memory 3217 (FIG. 29) (e.g., volatile andnon-volatile memory), and is electrically coupled to a battery 3211. Thebattery 3211 supplies power to the first stage circuit 3404, the secondstage circuit 3406, and a third stage circuit 3408, respectively. Aspreviously discussed, the control circuit 3200 generates a digitalwaveform 4300 (FIG. 36) using circuits and techniques described inconnection with FIGS. 41 and 42. Returning to FIG. 29, the digitalwaveform 4300 may be configured to drive an ultrasonic transducer,high-frequency (e.g., RF) electrodes, or a combination thereof eitherindependently or simultaneously. If driven simultaneously, filtercircuits may be provided in the corresponding first stage circuits 3404to select either the ultrasonic waveform or the RF waveform. Suchfiltering techniques are described in commonly owned U.S. Pat. Pub. No.US-2017-0086910-A1, titled TECHNIQUES FOR CIRCUIT TOPOLOGIES FORCOMBINED GENERATOR, which is herein incorporated by reference in itsentirety.

The first stage circuits 3404 (e.g., the first stage ultrasonic drivecircuit 3420, the first stage RF drive circuit 3422, and the first stagesensor drive circuit 3424) are located in a handle assembly 3412 of thesurgical instrument. The control circuit 3200 provides the ultrasonicdrive signal to the first stage ultrasonic drive circuit 3420 viaoutputs SCL-A, SDA-A of the control circuit 3200. The first stageultrasonic drive circuit 3420 is described in detail in connection withFIG. 26. The control circuit 3200 provides the RF drive signal to thefirst stage RF drive circuit 3422 via outputs SCL-B, SDA-B of thecontrol circuit 3200. The first stage RF drive circuit 3422 is describedin detail in connection with FIG. 31. The control circuit 3200 providesthe sensor drive signal to the first stage sensor drive circuit 3424 viaoutputs SCL-C, SDA-C of the control circuit 3200. Generally, each of thefirst stage circuits 3404 includes a digital-to-analog (DAC) converterand a first stage amplifier section to drive the second stage circuits3406. The outputs of the first stage circuits 3404 are provided to theinputs of the second stage circuits 3406.

The control circuit 3200 is configured to detect which modules areplugged into the control circuit 3200. For example, the control circuit3200 is configured to detect whether the first stage ultrasonic drivecircuit 3420, the first stage RF drive circuit 3422, or the first stagesensor drive circuit 3424 located in the handle assembly 3412 isconnected to the battery assembly 3410. Likewise, each of the firststage circuits 3404 can detect which second stage circuits 3406 areconnected thereto and that information is provided back to the controlcircuit 3200 to determine the type of signal waveform to generate.Similarly, each of the second stage circuits 3406 can detect which thirdstage circuits 3408 or components are connected thereto and thatinformation is provided back to the control circuit 3200 to determinethe type of signal waveform to generate.

In one aspect, the second stage circuits 3406 (e.g., the ultrasonicdrive second stage circuit 3430, the RF drive second stage circuit 3432,and the sensor drive second stage circuit 3434) are located in the shaftassembly 3414 of the surgical instrument. The first stage ultrasonicdrive circuit 3420 provides a signal to the second stage ultrasonicdrive circuit 3430 via outputs US-Left/US-Right. The second stageultrasonic drive circuit 3430 is described in detail in connection withFIGS. 30 and 31. In addition to a transformer (FIGS. 30 and 31), thesecond stage ultrasonic drive circuit 3430 also may include filter,amplifier, and signal conditioning circuits. The first stagehigh-frequency (RF) current drive circuit 3422 provides a signal to thesecond stage RF drive circuit 3432 via outputs RF-Left/RF-Right. Inaddition to a transformer and blocking capacitors, the second stage RFdrive circuit 3432 also may include filter, amplifier, and signalconditioning circuits. The first stage sensor drive circuit 3424provides a signal to the second stage sensor drive circuit 3434 viaoutputs Sensor-1/Sensor-2. The second stage sensor drive circuit 3434may include filter, amplifier, and signal conditioning circuitsdepending on the type of sensor. The outputs of the second stagecircuits 3406 are provided to the inputs of the third stage circuits3408.

In one aspect, the third stage circuits 3408 (e.g., the ultrasonictransducer 1120, the RF electrodes 3074 a, 3074 b, and the sensors 3440)may be located in various assemblies 3416 of the surgical instruments.In one aspect, the second stage ultrasonic drive circuit 3430 provides adrive signal to the ultrasonic transducer 1120 piezoelectric stack. Inone aspect, the ultrasonic transducer 1120 is located in the ultrasonictransducer assembly of the surgical instrument. In other aspects,however, the ultrasonic transducer 1120 may be located in the handleassembly 3412, the shaft assembly 3414, or the end effector. In oneaspect, the second stage RF drive circuit 3432 provides a drive signalto the RF electrodes 3074 a, 3074 b, which are generally located in theend effector portion of the surgical instrument. In one aspect, thesecond stage sensor drive circuit 3434 provides a drive signal tovarious sensors 3440 located throughout the surgical instrument.

FIG. 30 illustrates a generator circuit 3500 partitioned into multiplestages where a first stage circuit 3504 is common to the second stagecircuit 3506, in accordance with at least one aspect of the presentdisclosure. In one aspect, the surgical instruments of surgical system1000 described herein may comprise generator circuit 3500 partitionedinto multiple stages. For example, the surgical instruments of surgicalsystem 1000 may comprise the generator circuit 3500 partitioned into atleast two circuits: the first stage circuit 3504 and the second stagecircuit 3506 of amplification enabling operation of high-frequency (RF)energy only, ultrasonic energy only, and/or a combination of RF energyand ultrasonic energy. A combination modular shaft assembly 3514 may bepowered by a common first stage circuit 3504 located within the handleassembly 3512 and a modular second stage circuit 3506 integral to themodular shaft assembly 3514. As previously discussed throughout thisdescription in connection with the surgical instruments of surgicalsystem 1000, a battery assembly 3510 and the shaft assembly 3514 areconfigured to mechanically and electrically connect to the handleassembly 3512. The end effector assembly is configured to mechanicallyand electrically connect the shaft assembly 3514.

As shown in the example of FIG. 30, the battery assembly 3510 portion ofthe surgical instrument comprises a first control circuit 3502, whichincludes the control circuit 3200 previously described. The handleassembly 3512, which connects to the battery assembly 3510, comprises acommon first stage drive circuit 3420. As previously discussed, thefirst stage drive circuit 3420 is configured to drive ultrasonic,high-frequency (RF) current, and sensor loads. The output of the commonfirst stage drive circuit 3420 can drive any one of the second stagecircuits 3506 such as the second stage ultrasonic drive circuit 3430,the second stage high-frequency (RF) current drive circuit 3432, and/orthe second stage sensor drive circuit 3434. The common first stage drivecircuit 3420 detects which second stage circuit 3506 is located in theshaft assembly 3514 when the shaft assembly 3514 is connected to thehandle assembly 3512. Upon the shaft assembly 3514 being connected tothe handle assembly 3512, the common first stage drive circuit 3420determines which one of the second stage circuits 3506 (e.g., the secondstage ultrasonic drive circuit 3430, the second stage RF drive circuit3432, and/or the second stage sensor drive circuit 3434) is located inthe shaft assembly 3514. The information is provided to the controlcircuit 3200 located in the handle assembly 3512 in order to supply asuitable digital waveform 4300 (FIG. 36) to the second stage circuit3506 to drive the appropriate load, e.g., ultrasonic, RF, or sensor. Itwill be appreciated that identification circuits may be included invarious assemblies 3516 in third stage circuit 3508 such as theultrasonic transducer 1120, the electrodes 3074 a, 3074 b, or thesensors 3440. Thus, when a third stage circuit 3508 is connected to asecond stage circuit 3506, the second stage circuit 3506 knows the typeof load that is required based on the identification information.

FIG. 31 is a schematic diagram of one aspect of an electrical circuit3600 configured to drive a high-frequency current (RF), in accordancewith at least one aspect of the present disclosure. The electricalcircuit 3600 comprises an analog multiplexer 3680. The analogmultiplexer 3680 multiplexes various signals from the upstream channelsSCL-A, SDA-A such as RF, battery, and power control circuit. A currentsensor 3682 is coupled in series with the return or ground leg of thepower supply circuit to measure the current supplied by the powersupply. A field effect transistor (FET) temperature sensor 3684 providesthe ambient temperature. A pulse width modulation (PWM) watchdog timer3688 automatically generates a system reset if the main program neglectsto periodically service it. It is provided to automatically reset theelectrical circuit 3600 when it hangs or freezes because of a softwareor hardware fault. It will be appreciated that the electrical circuit3600 may be configured for driving RF electrodes or for driving theultrasonic transducer 1120 as described in connection with FIG. 26, forexample. Accordingly, with reference now back to FIG. 31, the electricalcircuit 3600 can be used to drive both ultrasonic and RF electrodesinterchangeably.

A drive circuit 3686 provides Left and Right RF energy outputs. Adigital signal that represents the signal waveform is provided to theSCL-A, SDA-A inputs of the analog multiplexer 3680 from a controlcircuit, such as the control circuit 3200 (FIG. 27). A digital-to-analogconverter 3690 (DAC) converts the digital input to an analog output todrive a PWM circuit 3692 coupled to an oscillator 3694. The PWM circuit3692 provides a first signal to a first gate drive circuit 3696 acoupled to a first transistor output stage 3698 a to drive a first RF+(Left) energy output. The PWM circuit 3692 also provides a second signalto a second gate drive circuit 3696 b coupled to a second transistoroutput stage 3698 b to drive a second RF− (Right) energy output. Avoltage sensor 3699 is coupled between the RF Left/RF output terminalsto measure the output voltage. The drive circuit 3686, the first andsecond drive circuits 3696 a, 3696 b, and the first and secondtransistor output stages 3698 a, 3698 b define a first stage amplifiercircuit. In operation, the control circuit 3200 (FIG. 27) generates adigital waveform 4300 (FIG. 36) employing circuits such as directdigital synthesis (DDS) circuits 4100, 4200 (FIGS. 41 and 42). The DAC3690 receives the digital waveform 4300 and converts it into an analogwaveform, which is received and amplified by the first stage amplifiercircuit.

FIG. 32 illustrates the control circuit 3900 that allows a dualgenerator system to switch between the RF generator circuit 3902 and theultrasonic generator circuit 3920 energy modalities for a surgicalinstrument of the surgical system 1000. In one aspect, a currentthreshold in an RF signal is detected. When the impedance of the tissueis low the high-frequency current through tissue is high when RF energyis used as the treatment source for the tissue. According to one aspect,a visual indicator 3912 or light located on the surgical instrument ofsurgical system 1000 may be configured to be in an on-state during thishigh current period. When the current falls below a threshold, thevisual indicator 3912 is in an off-state. Accordingly, a phototransistor3914 may be configured to detect the transition from an on-state to anoff-state and disengages the RF energy as shown in the control circuit3900 shown in FIG. 32. Therefore, when the energy button is released andan energy switch 3926 is opened, the control circuit 3900 is reset andboth the RF and ultrasonic generator circuits 3902, 3920 are held off.

With reference to FIG. 39, in one aspect, a method of managing an RFgenerator circuit 3902 and ultrasound generator circuit 3920 isprovided. The RF generator circuit 3902 and/or the ultrasound generatorcircuit 3920 may be located in the handle assembly 1109, the ultrasonictransducer/RF generator assembly 1120, the battery assembly, the shaftassembly 1129, and/or the nozzle, of the multifunction electrosurgicalinstrument 1108, for example. The control circuit 3900 is held in areset state if the energy switch 3926 is off (e.g., open). Thus, whenthe energy switch 3926 is opened, the control circuit 3900 is reset andboth the RF and ultrasonic generator circuits 3902, 3920 are turned off.When the energy switch 3926 is squeezed and the energy switch 3926 isengaged (e.g., closed), RF energy is delivered to the tissue and thevisual indicator 3912 operated by a current sensing step-up transformer3904 will be lit while the tissue impedance is low. The light from thevisual indicator 3912 provides a logic signal to keep the ultrasonicgenerator circuit 3920 in the off state. Once the tissue impedanceincreases above a threshold and the high-frequency current through thetissue decreases below a threshold, the visual indicator 3912 turns offand the light transitions to an off-state. A logic signal generated bythis transition turns off a relay 3908, whereby the RF generator circuit3902 is turned off and the ultrasonic generator circuit 3920 is turnedon, to complete the coagulation and cut cycle.

Still with reference to FIG. 39, in one aspect, the dual generatorcircuit configuration employs the on-board RF generator circuit 3902,which is battery 3901 powered, for one modality and a second, on-boardultrasound generator circuit 3920, which may be on-board in the handleassembly 1109, battery assembly, shaft assembly 1129, nozzle, and/or theultrasonic transducer/RF generator assembly 1120 of the multifunctionelectrosurgical instrument 1108, for example. The ultrasonic generatorcircuit 3920 also is battery 3901 operated. In various aspects, the RFgenerator circuit 3902 and the ultrasonic generator circuit 3920 may bean integrated or separable component of the handle assembly 1109.According to various aspects, having the dual RF/ultrasonic generatorcircuits 3902, 3920 as part of the handle assembly 1109 may eliminatethe need for complicated wiring. The RF/ultrasonic generator circuits3902, 3920 may be configured to provide the full capabilities of anexisting generator while utilizing the capabilities of a cordlessgenerator system simultaneously.

Either type of system can have separate controls for the modalities thatare not communicating with each other. The surgeon activates the RF andUltrasonic separately and at their discretion. Another approach would beto provide fully integrated communication schemes that share buttons,tissue status, instrument operating parameters (such as jaw closure,forces, etc.) and algorithms to manage tissue treatment. Variouscombinations of this integration can be implemented to provide theappropriate level of function and performance.

As discussed above, in one aspect, the control circuit 3900 includes thebattery 3901 powered RF generator circuit 3902 comprising a battery asan energy source. As shown, RF generator circuit 3902 is coupled to twoelectrically conductive surfaces referred to herein as electrodes 3906a, 3906 b (i.e., active electrode 3906 a and return electrode 3906 b)and is configured to drive the electrodes 3906 a, 3906 b with RF energy(e.g., high-frequency current). A first winding 3910 a of the step-uptransformer 3904 is connected in series with one pole of the bipolar RFgenerator circuit 3902 and the return electrode 3906 b. In one aspect,the first winding 3910 a and the return electrode 3906 b are connectedto the negative pole of the bipolar RF generator circuit 3902. The otherpole of the bipolar RF generator circuit 3902 is connected to the activeelectrode 3906 a through a switch contact 3909 of the relay 3908, or anysuitable electromagnetic switching device comprising an armature whichis moved by an electromagnet 3936 to operate the switch contact 3909.The switch contact 3909 is closed when the electromagnet 3936 isenergized and the switch contact 3909 is open when the electromagnet3936 is de-energized. When the switch contact is closed, RF currentflows through conductive tissue (not shown) located between theelectrodes 3906 a, 3906 b. It will be appreciated, that in one aspect,the active electrode 3906 a is connected to the positive pole of thebipolar RF generator circuit 3902.

A visual indicator circuit 3905 comprises the step-up transformer 3904,a series resistor R2, and the visual indicator 3912. The visualindicator 3912 can be adapted for use with the surgical instrument 1108and other electrosurgical systems and tools, such as those describedherein. The first winding 3910 a of the step-up transformer 3904 isconnected in series with the return electrode 3906 b and the secondwinding 3910 b of the step-up transformer 3904 is connected in serieswith the resistor R2 and the visual indicator 3912 comprising a typeNE-2 neon bulb, for example.

In operation, when the switch contact 3909 of the relay 3908 is open,the active electrode 3906 a is disconnected from the positive pole ofthe bipolar RF generator circuit 3902 and no current flows through thetissue, the return electrode 3906 b, and the first winding 3910 a of thestep-up transformer 3904. Accordingly, the visual indicator 3912 is notenergized and does not emit light. When the switch contact 3909 of therelay 3908 is closed, the active electrode 3906 a is connected to thepositive pole of the bipolar RF generator circuit 3902 enabling currentto flow through tissue, the return electrode 3906 b, and the firstwinding 3910 a of the step-up transformer 3904 to operate on tissue, forexample cut and cauterize the tissue. A first current flows through thefirst winding 3910 a as a function of the impedance of the tissuelocated between the active and return electrodes 3906 a, 3906 bproviding a first voltage across the first winding 3910 a of the step-uptransformer 3904. A stepped up second voltage is induced across thesecond winding 3910 b of the step-up transformer 3904. The secondaryvoltage appears across the resistor R2 and energizes the visualindicator 3912 causing the neon bulb to light when the current throughthe tissue is greater than a predetermined threshold. It will beappreciated that the circuit and component values are illustrative andnot limited thereto. When the switch contact 3909 of the relay 3908 isclosed, current flows through the tissue and the visual indicator 3912is turned on.

Turning now to the energy switch 3926 portion of the control circuit3900, when the energy switch 3926 is open position, a logic high isapplied to the input of a first inverter 3928 and a logic low is appliedof one of the two inputs of the AND gate 3932. Thus, the output of theAND gate 3932 is low and a transistor 3934 is off to prevent currentfrom flowing through the winding of the electromagnet 3936. With theelectromagnet 3936 in the de-energized state, the switch contact 3909 ofthe relay 3908 remains open and prevents current from flowing throughthe electrodes 3906 a, 3906 b. The logic low output of the firstinverter 3928 also is applied to a second inverter 3930 causing theoutput to go high and resetting a flip-flop 3918 (e.g., a D-Typeflip-flop). At which time, the Q output goes low to turn off theultrasound generator circuit 3920 circuit and the Q output goes high andis applied to the other input of the AND gate 3932.

When the user presses the energy switch 3926 on the instrument handle toapply energy to the tissue between the electrodes 3906 a, 3906 b, theenergy switch 3926 closes and applies a logic low at the input of thefirst inverter 3928, which applies a logic high to other input of theAND gate 3932 causing the output of the AND gate 3932 to go high andturns on the transistor 3934. In the on state, the transistor 3934conducts and sinks current through the winding of the electromagnet 3936to energize the electromagnet 3936 and close the switch contact 3909 ofthe relay 3908. As discussed above, when the switch contact 3909 isclosed, current can flow through the electrodes 3906 a, 3906 b and thefirst winding 3910 a of the step-up transformer 3904 when tissue islocated between the electrodes 3906 a, 3906 b.

As discussed above, the magnitude of the current flowing through theelectrodes 3906 a, 3906 b depends on the impedance of the tissue locatedbetween the electrodes 3906 a, 3906 b. Initially, the tissue impedanceis low and the magnitude of the current high through the tissue and thefirst winding 3910 a. Consequently, the voltage impressed on the secondwinding 3910 b is high enough to turn on the visual indicator 3912. Thelight emitted by the visual indicator 3912 turns on the phototransistor3914, which pulls the input of an inverter 3916 low and causes theoutput of the inverter 3916 to go high. A high input applied to the CLKof the flip-flop 3918 has no effect on the Q or the Q outputs of theflip-flop 3918 and Q output remains low and the Q output remains high.Accordingly, while the visual indicator 3912 remains energized, theultrasound generator circuit 3920 is turned OFF and an ultrasonictransducer 3922 and an ultrasonic blade 3924 of the multifunctionelectrosurgical instrument are not activated.

As the tissue between the electrodes 3906 a, 3906 b dries up, due to theheat generated by the current flowing through the tissue, the impedanceof the tissue increases and the current therethrough decreases. When thecurrent through the first winding 3910 a decreases, the voltage acrossthe second winding 3910 b also decreases and when the voltage dropsbelow a minimum threshold required to operate the visual indicator 3912,the visual indicator 3912 and the phototransistor 3914 turn off. Whenthe phototransistor 3914 turns off, a logic high is applied to the inputof the inverter 3916 and a logic low is applied to the CLK input of theflip-flop 3918 to clock a logic high to the Q output and a logic low tothe Q output. The logic high at the Q output turns on the ultrasoundgenerator circuit 3920 to activate the ultrasonic transducer 3922 andthe ultrasonic blade 3924 to initiate cutting the tissue located betweenthe electrodes 3906 a, 3906 a. Simultaneously or near simultaneouslywith the ultrasound generator circuit 3920 turning on, the Q output ofthe flip-flop 3918 goes low and causes the output of the AND gate 3932to go low and turn off the transistor 3934, thereby de-energizing theelectromagnet 3936 and opening the switch contact 3909 of the relay 3908to cut off the flow of current through the electrodes 3906 a, 3906 b.

While the switch contact 3909 of the relay 3908 is open, no currentflows through the electrodes 3906 a, 3906 b, tissue, and the firstwinding 3910 a of the step-up transformer 3904. Therefore, no voltage isdeveloped across the second winding 3910 b and no current flows throughthe visual indicator 3912.

The state of the Q and the Q outputs of the flip-flop 3918 remain thesame while the user squeezes the energy switch 3926 on the instrumenthandle to maintain the energy switch 3926 closed. Thus, the ultrasonicblade 3924 remains activated and continues cutting the tissue betweenthe jaws of the end effector while no current flows through theelectrodes 3906 a, 3906 b from the bipolar RF generator circuit 3902.When the user releases the energy switch 3926 on the instrument handle,the energy switch 3926 opens and the output of the first inverter 3928goes low and the output of the second inverter 3930 goes high to resetthe flip-flop 3918 causing the Q output to go low and turn off theultrasound generator circuit 3920. At the same time, the Q output goeshigh and the circuit is now in an off state and ready for the user toactuate the energy switch 3926 on the instrument handle to close theenergy switch 3926, apply current to the tissue located between theelectrodes 3906 a, 3906 b, and repeat the cycle of applying RF energy tothe tissue and ultrasonic energy to the tissue as described above.

FIG. 33 illustrates a diagram of a surgical system 4000, whichrepresents one aspect of the surgical system 1000, comprising a feedbacksystem for use with any one of the surgical instruments of surgicalsystem 1000, which may include or implement many of the featuresdescribed herein. The surgical system 4000 may include a generator 4002coupled to a surgical instrument that includes an end effector 4006,which may be activated when a clinician operates a trigger 4010. Invarious aspects, the end effector 4006 may include an ultrasonic bladeto deliver ultrasonic vibration to carry out surgicalcoagulation/cutting treatments on living tissue. In other aspects theend effector 4006 may include electrically conductive elements coupledto an electrosurgical high-frequency current energy source to carry outsurgical coagulation or cauterization treatments on living tissue andeither a mechanical knife with a sharp edge or an ultrasonic blade tocarry out cutting treatments on living tissue. When the trigger 4010 isactuated, a force sensor 4012 may generate a signal indicating theamount of force being applied to the trigger 4010. In addition to, orinstead of a force sensor 4012, the surgical instrument may include aposition sensor 4013, which may generate a signal indicating theposition of the trigger 4010 (e.g., how far the trigger has beendepressed or otherwise actuated). In one aspect, the position sensor4013 may be a sensor positioned with an outer tubular sheath orreciprocating tubular actuating member located within the outer tubularsheath of the surgical instrument. In one aspect, the sensor may be aHall-effect sensor or any suitable transducer that varies its outputvoltage in response to a magnetic field. The Hall-effect sensor may beused for proximity switching, positioning, speed detection, and currentsensing applications. In one aspect, the Hall-effect sensor operates asan analog transducer, directly returning a voltage. With a knownmagnetic field, its distance from the Hall plate can be determined.

A control circuit 4008 may receive the signals from the sensors 4012and/or 4013. The control circuit 4008 may include any suitable analog ordigital circuit components. The control circuit 4008 also maycommunicate with the generator 4002 and/or a transducer 4004 to modulatethe power delivered to the end effector 4006 and/or the generator levelor ultrasonic blade amplitude of the end effector 4006 based on theforce applied to the trigger 4010 and/or the position of the trigger4010 and/or the position of the outer tubular sheath described aboverelative to a reciprocating tubular actuating member located within anouter tubular sheath (e.g., as measured by a Hall-effect sensor andmagnet combination). For example, as more force is applied to thetrigger 4010, more power and/or higher ultrasonic blade amplitude may bedelivered to the end effector 4006. According to various aspects, theforce sensor 4012 may be replaced by a multi-position switch.

According to various aspects, the end effector 4006 may include a clampor clamping mechanism. When the trigger 4010 is initially actuated, theclamping mechanism may close, clamping tissue between a clamp arm andthe end effector 4006. As the force applied to the trigger increases(e.g., as sensed by force sensor 4012) the control circuit 4008 mayincrease the power delivered to the end effector 4006 by the transducer4004 and/or the generator level or ultrasonic blade amplitude broughtabout in the end effector 4006. In one aspect, trigger position, assensed by position sensor 4013 or clamp or clamp arm position, as sensedby position sensor 4013 (e.g., with a Hall-effect sensor), may be usedby the control circuit 4008 to set the power and/or amplitude of the endeffector 4006. For example, as the trigger is moved further towards afully actuated position, or the clamp or clamp arm moves further towardsthe ultrasonic blade (or end effector 4006), the power and/or amplitudeof the end effector 4006 may be increased.

According to various aspects, the surgical instrument of the surgicalsystem 4000 also may include one or more feedback devices for indicatingthe amount of power delivered to the end effector 4006. For example, aspeaker 4014 may emit a signal indicative of the end effector power.According to various aspects, the speaker 4014 may emit a series ofpulse sounds, where the frequency of the sounds indicates power. Inaddition to, or instead of the speaker 4014, the surgical instrument mayinclude a visual display 4016. The visual display 4016 may indicate endeffector power according to any suitable method. For example, the visualdisplay 4016 may include a series of LEDs, where end effector power isindicated by the number of illuminated LEDs. The speaker 4014 and/orvisual display 4016 may be driven by the control circuit 4008. Accordingto various aspects, the surgical instrument may include a ratchetingdevice connected to the trigger 4010. The ratcheting device may generatean audible sound as more force is applied to the trigger 4010, providingan indirect indication of end effector power. The surgical instrumentmay include other features that may enhance safety. For example, thecontrol circuit 4008 may be configured to prevent power from beingdelivered to the end effector 4006 in excess of a predeterminedthreshold. Also, the control circuit 4008 may implement a delay betweenthe time when a change in end effector power is indicated (e.g., byspeaker 4014 or visual display 4016), and the time when the change inend effector power is delivered. In this way, a clinician may have amplewarning that the level of ultrasonic power that is to be delivered tothe end effector 4006 is about to change.

In one aspect, the ultrasonic or high-frequency current generators ofthe surgical system 1000 may be configured to generate the electricalsignal waveform digitally such that the desired using a predeterminednumber of phase points stored in a lookup table to digitize the waveshape. The phase points may be stored in a table defined in a memory, afield programmable gate array (FPGA), or any suitable non-volatilememory. FIG. 34 illustrates one aspect of a fundamental architecture fora digital synthesis circuit such as a direct digital synthesis (DDS)circuit 4100 configured to generate a plurality of wave shapes for theelectrical signal waveform. The generator software and digital controlsmay command the FPGA to scan the addresses in the lookup table 4104which in turn provides varying digital input values to a DAC circuit4108 that feeds a power amplifier. The addresses may be scannedaccording to a frequency of interest. Using such a lookup table 4104enables generating various types of wave shapes that can be fed intotissue or into a transducer, an RF electrode, multiple transducerssimultaneously, multiple RF electrodes simultaneously, or a combinationof RF and ultrasonic instruments. Furthermore, multiple lookup tables4104 that represent multiple wave shapes can be created, stored, andapplied to tissue from a generator.

The waveform signal may be configured to control at least one of anoutput current, an output voltage, or an output power of an ultrasonictransducer and/or an RF electrode, or multiples thereof (e.g. two ormore ultrasonic transducers and/or two or more RF electrodes). Further,where the surgical instrument comprises an ultrasonic components, thewaveform signal may be configured to drive at least two vibration modesof an ultrasonic transducer of the at least one surgical instrument.Accordingly, a generator may be configured to provide a waveform signalto at least one surgical instrument wherein the waveform signalcorresponds to at least one wave shape of a plurality of wave shapes ina table. Further, the waveform signal provided to the two surgicalinstruments may comprise two or more wave shapes. The table may compriseinformation associated with a plurality of wave shapes and the table maybe stored within the generator. In one aspect or example, the table maybe a direct digital synthesis table, which may be stored in an FPGA ofthe generator. The table may be addressed by anyway that is convenientfor categorizing wave shapes. According to one aspect, the table, whichmay be a direct digital synthesis table, is addressed according to afrequency of the waveform signal. Additionally, the informationassociated with the plurality of wave shapes may be stored as digitalinformation in the table.

The analog electrical signal waveform may be configured to control atleast one of an output current, an output voltage, or an output power ofan ultrasonic transducer and/or an RF electrode, or multiples thereof(e.g., two or more ultrasonic transducers and/or two or more RFelectrodes). Further, where the surgical instrument comprises ultrasoniccomponents, the analog electrical signal waveform may be configured todrive at least two vibration modes of an ultrasonic transducer of the atleast one surgical instrument. Accordingly, the generator circuit may beconfigured to provide an analog electrical signal waveform to at leastone surgical instrument wherein the analog electrical signal waveformcorresponds to at least one wave shape of a plurality of wave shapesstored in a lookup table 4104. Further, the analog electrical signalwaveform provided to the two surgical instruments may comprise two ormore wave shapes. The lookup table 4104 may comprise informationassociated with a plurality of wave shapes and the lookup table 4104 maybe stored either within the generator circuit or the surgicalinstrument. In one aspect or example, the lookup table 4104 may be adirect digital synthesis table, which may be stored in an FPGA of thegenerator circuit or the surgical instrument. The lookup table 4104 maybe addressed by anyway that is convenient for categorizing wave shapes.According to one aspect, the lookup table 4104, which may be a directdigital synthesis table, is addressed according to a frequency of thedesired analog electrical signal waveform. Additionally, the informationassociated with the plurality of wave shapes may be stored as digitalinformation in the lookup table 4104.

With the widespread use of digital techniques in instrumentation andcommunications systems, a digitally-controlled method of generatingmultiple frequencies from a reference frequency source has evolved andis referred to as direct digital synthesis. The basic architecture isshown in FIG. 34. In this simplified block diagram, a DDS circuit iscoupled to a processor, controller, or a logic device of the generatorcircuit and to a memory circuit located in the generator circuit of thesurgical system 1000. The DDS circuit 4100 comprises an address counter4102, lookup table 4104, a register 4106, a DAC circuit 4108, and afilter 4112. A stable clock f_(c) is received by the address counter4102 and the register 4106 drives a programmable-read-only-memory (PROM)which stores one or more integral number of cycles of a sinewave (orother arbitrary waveform) in a lookup table 4104. As the address counter4102 steps through memory locations, values stored in the lookup table4104 are written to the register 4106, which is coupled to the DACcircuit 4108. The corresponding digital amplitude of the signal at thememory location of the lookup table 4104 drives the DAC circuit 4108,which in turn generates an analog output signal 4110. The spectralpurity of the analog output signal 4110 is determined primarily by theDAC circuit 4108. The phase noise is basically that of the referenceclock f_(c). The first analog output signal 4110 output from the DACcircuit 4108 is filtered by the filter 4112 and a second analog outputsignal 4114 output by the filter 4112 is provided to an amplifier havingan output coupled to the output of the generator circuit. The secondanalog output signal has a frequency f_(out).

Because the DDS circuit 4100 is a sampled data system, issues involvedin sampling must be considered: quantization noise, aliasing, filtering,etc. For instance, the higher order harmonics of the DAC circuit 4108output frequencies fold back into the Nyquist bandwidth, making themunfilterable, whereas, the higher order harmonics of the output ofphase-locked-loop (PLL) based synthesizers can be filtered. The lookuptable 4104 contains signal data for an integral number of cycles. Thefinal output frequency f_(out) can be changed changing the referenceclock frequency f_(c) or by reprogramming the PROM.

The DDS circuit 4100 may comprise multiple lookup tables 4104 where thelookup table 4104 stores a waveform represented by a predeterminednumber of samples, wherein the samples define a predetermined shape ofthe waveform. Thus multiple waveforms having a unique shape can bestored in multiple lookup tables 4104 to provide different tissuetreatments based on instrument settings or tissue feedback. Examples ofwaveforms include high crest factor RF electrical signal waveforms forsurface tissue coagulation, low crest factor RF electrical signalwaveform for deeper tissue penetration, and electrical signal waveformsthat promote efficient touch-up coagulation. In one aspect, the DDScircuit 4100 can create multiple wave shape lookup tables 4104 andduring a tissue treatment procedure (e.g., “on-the-fly” or in virtualreal time based on user or sensor inputs) switch between different waveshapes stored in separate lookup tables 4104 based on the tissue effectdesired and/or tissue feedback.

Accordingly, switching between wave shapes can be based on tissueimpedance and other factors, for example. In other aspects, the lookuptables 4104 can store electrical signal waveforms shaped to maximize thepower delivered into the tissue per cycle (i.e., trapezoidal or squarewave). In other aspects, the lookup tables 4104 can store wave shapessynchronized in such way that they make maximizing power delivery by themultifunction surgical instrument of surgical system 1000 whiledelivering RF and ultrasonic drive signals. In yet other aspects, thelookup tables 4104 can store electrical signal waveforms to driveultrasonic and RF therapeutic, and/or sub-therapeutic, energysimultaneously while maintaining ultrasonic frequency lock. Custom waveshapes specific to different instruments and their tissue effects can bestored in the non-volatile memory of the generator circuit or in thenon-volatile memory (e.g., EEPROM) of the surgical system 1000 and befetched upon connecting the multifunction surgical instrument to thegenerator circuit. An example of an exponentially damped sinusoid, asused in many high crest factor “coagulation” waveforms is shown in FIG.36.

A more flexible and efficient implementation of the DDS circuit 4100employs a digital circuit called a Numerically Controlled Oscillator(NCO). A block diagram of a more flexible and efficient digitalsynthesis circuit such as a DDS circuit 4200 is shown in FIG. 35. Inthis simplified block diagram, a DDS circuit 4200 is coupled to aprocessor, controller, or a logic device of the generator and to amemory circuit located either in the generator or in any of the surgicalinstruments of surgical system 1000. The DDS circuit 4200 comprises aload register 4202, a parallel delta phase register 4204, an addercircuit 4216, a phase register 4208, a lookup table 4210(phase-to-amplitude converter), a DAC circuit 4212, and a filter 4214.The adder circuit 4216 and the phase register 4208 form part of a phaseaccumulator 4206. A clock frequency f_(c) is applied to the phaseregister 4208 and a DAC circuit 4212. The load register 4202 receives atuning word that specifies output frequency as a fraction of thereference clock frequency signal f_(c). The output of the load register4202 is provided to the parallel delta phase register 4204 with a tuningword M.

The DDS circuit 4200 includes a sample clock that generates the clockfrequency f_(c), the phase accumulator 4206, and the lookup table 4210(e.g., phase to amplitude converter). The content of the phaseaccumulator 4206 is updated once per clock cycle f_(c). When time thephase accumulator 4206 is updated, the digital number, M, stored in theparallel delta phase register 4204 is added to the number in the phaseregister 4208 by the adder circuit 4216. Assuming that the number in theparallel delta phase register 4204 is 00 . . . 01 and that the initialcontents of the phase accumulator 4206 is 00 . . . 00. The phaseaccumulator 4206 is updated by 00 . . . 01 per clock cycle. If the phaseaccumulator 4206 is 32-bits wide, 232 clock cycles (over 4 billion) arerequired before the phase accumulator 4206 returns to 00 . . . 00, andthe cycle repeats.

A truncated output 4218 of the phase accumulator 4206 is provided to aphase-to amplitude converter lookup table 4210 and the output of thelookup table 4210 is coupled to a DAC circuit 4212. The truncated output4218 of the phase accumulator 4206 serves as the address to a sine (orcosine) lookup table. An address in the lookup table corresponds to aphase point on the sinewave from 0° to 360°. The lookup table 4210contains the corresponding digital amplitude information for onecomplete cycle of a sinewave. The lookup table 4210 therefore maps thephase information from the phase accumulator 4206 into a digitalamplitude word, which in turn drives the DAC circuit 4212. The output ofthe DAC circuit is a first analog signal 4220 and is filtered by afilter 4214. The output of the filter 4214 is a second analog signal4222, which is provided to a power amplifier coupled to the output ofthe generator circuit.

In one aspect, the electrical signal waveform may be digitized into 1024(210) phase points, although the wave shape may be digitized is anysuitable number of 2n phase points ranging from 256 (28) to281,474,976,710,656 (248), where n is a positive integer, as shown inTABLE 1. The electrical signal waveform may be expressed asA_(n)(θ_(n)), where a normalized amplitude A_(n) at a point n isrepresented by a phase angle θ_(n) is referred to as a phase point atpoint n. The number of discrete phase points n determines the tuningresolution of the DDS circuit 4200 (as well as the DDS circuit 4100shown in FIG. 34).

TABLE 1 specifies the electrical signal waveform digitized into a numberof phase points.

TABLE 1 N Number of Phase Points 2^(n)  8 256 10 1,024 12 4,096 1416,384 16 65,536 18 262,144 20 1,048,576 22 4,194,304 24 16,777,216 2667,108,864 28 268,435,456 . . . . . . 32 4,294,967,296 . . . . . . 48281,474,976,710,656 . . . . . .

The generator circuit algorithms and digital control circuits scan theaddresses in the lookup table 4210, which in turn provides varyingdigital input values to the DAC circuit 4212 that feeds the filter 4214and the power amplifier. The addresses may be scanned according to afrequency of interest. Using the lookup table enables generating varioustypes of shapes that can be converted into an analog output signal bythe DAC circuit 4212, filtered by the filter 4214, amplified by thepower amplifier coupled to the output of the generator circuit, and fedto the tissue in the form of RF energy or fed to an ultrasonictransducer and applied to the tissue in the form of ultrasonicvibrations which deliver energy to the tissue in the form of heat. Theoutput of the amplifier can be applied to an RF electrode, multiple RFelectrodes simultaneously, an ultrasonic transducer, multiple ultrasonictransducers simultaneously, or a combination of RF and ultrasonictransducers, for example. Furthermore, multiple wave shape tables can becreated, stored, and applied to tissue from a generator circuit.

With reference back to FIG. 34, for n=32, and M=1, the phase accumulator4206 steps through 232 possible outputs before it overflows andrestarts. The corresponding output wave frequency is equal to the inputclock frequency divided by 232. If M=2, then the phase register 1708“rolls over” twice as fast, and the output frequency is doubled. Thiscan be generalized as follows.

For a phase accumulator 4206 configured to accumulate n-bits (ngenerally ranges from 24 to 32 in most DDS systems, but as previouslydiscussed n may be selected from a wide range of options), there are2^(n) possible phase points. The digital word in the delta phaseregister, M, represents the amount the phase accumulator is incrementedper clock cycle. If f_(c) is the clock frequency, then the frequency ofthe output sinewave is equal to:

$f_{0} = \frac{M \cdot f_{c}}{2^{n}}$

The above equation is known as the DDS “tuning equation.” Note that thefrequency resolution of the system is equal to

$\frac{f_{o}}{2^{n}}.$For n=32, the resolution is greater than one part in four billion. Inone aspect of the DDS circuit 4200, not all of the bits out of the phaseaccumulator 4206 are passed on to the lookup table 4210, but aretruncated, leaving only the first 13 to 15 most significant bits (MSBs),for example. This reduces the size of the lookup table 4210 and does notaffect the frequency resolution. The phase truncation only adds a smallbut acceptable amount of phase noise to the final output.

The electrical signal waveform may be characterized by a current,voltage, or power at a predetermined frequency. Further, where any oneof the surgical instruments of surgical system 1000 comprises ultrasoniccomponents, the electrical signal waveform may be configured to drive atleast two vibration modes of an ultrasonic transducer of the at leastone surgical instrument. Accordingly, the generator circuit may beconfigured to provide an electrical signal waveform to at least onesurgical instrument wherein the electrical signal waveform ischaracterized by a predetermined wave shape stored in the lookup table4210 (or lookup table 4104 FIG. 34). Further, the electrical signalwaveform may be a combination of two or more wave shapes. The lookuptable 4210 may comprise information associated with a plurality of waveshapes. In one aspect or example, the lookup table 4210 may be generatedby the DDS circuit 4200 and may be referred to as a direct digitalsynthesis table. DDS works by first storing a large repetitive waveformin onboard memory. A cycle of a waveform (sine, triangle, square,arbitrary) can be represented by a predetermined number of phase pointsas shown in TABLE 1 and stored into memory. Once the waveform is storedinto memory, it can be generated at very precise frequencies. The directdigital synthesis table may be stored in a non-volatile memory of thegenerator circuit and/or may be implemented with a FPGA circuit in thegenerator circuit. The lookup table 4210 may be addressed by anysuitable technique that is convenient for categorizing wave shapes.According to one aspect, the lookup table 4210 is addressed according toa frequency of the electrical signal waveform. Additionally, theinformation associated with the plurality of wave shapes may be storedas digital information in a memory or as part of the lookup table 4210.

In one aspect, the generator circuit may be configured to provideelectrical signal waveforms to at least two surgical instrumentssimultaneously. The generator circuit also may be configured to providethe electrical signal waveform, which may be characterized two or morewave shapes, via an output channel of the generator circuit to the twosurgical instruments simultaneously. For example, in one aspect theelectrical signal waveform comprises a first electrical signal to drivean ultrasonic transducer (e.g., ultrasonic drive signal), a second RFdrive signal, and/or a combination thereof. In addition, an electricalsignal waveform may comprise a plurality of ultrasonic drive signals, aplurality of RF drive signals, and/or a combination of a plurality ofultrasonic and RF drive signals.

In addition, a method of operating the generator circuit according tothe present disclosure comprises generating an electrical signalwaveform and providing the generated electrical signal waveform to anyone of the surgical instruments of surgical system 1000, wheregenerating the electrical signal waveform comprises receivinginformation associated with the electrical signal waveform from amemory. The generated electrical signal waveform comprises at least onewave shape. Furthermore, providing the generated electrical signalwaveform to the at least one surgical instrument comprises providing theelectrical signal waveform to at least two surgical instrumentssimultaneously.

The generator circuit as described herein may allow for the generationof various types of direct digital synthesis tables. Examples of waveshapes for RF/Electrosurgery signals suitable for treating a variety oftissue generated by the generator circuit include RF signals with a highcrest factor (which may be used for surface coagulation in RF mode), alow crest factor RF signals (which may be used for deeper tissuepenetration), and waveforms that promote efficient touch-up coagulation.The generator circuit also may generate multiple wave shapes employing adirect digital synthesis lookup table 4210 and, on the fly, can switchbetween particular wave shapes based on the desired tissue effect.Switching may be based on tissue impedance and/or other factors.

In addition to traditional sine/cosine wave shapes, the generatorcircuit may be configured to generate wave shape(s) that maximize thepower into tissue per cycle (i.e., trapezoidal or square wave). Thegenerator circuit may provide wave shape(s) that are synchronized tomaximize the power delivered to the load when driving RF and ultrasonicsignals simultaneously and to maintain ultrasonic frequency lock,provided that the generator circuit includes a circuit topology thatenables simultaneously driving RF and ultrasonic signals. Further,custom wave shapes specific to instruments and their tissue effects canbe stored in a non-volatile memory (NVM) or an instrument EEPROM and canbe fetched upon connecting any one of the surgical instruments ofsurgical system 1000 to the generator circuit.

The DDS circuit 4200 may comprise multiple lookup tables 4104 where thelookup table 4210 stores a waveform represented by a predeterminednumber of phase points (also may be referred to as samples), wherein thephase points define a predetermined shape of the waveform. Thus multiplewaveforms having a unique shape can be stored in multiple lookup tables4210 to provide different tissue treatments based on instrument settingsor tissue feedback. Examples of waveforms include high crest factor RFelectrical signal waveforms for surface tissue coagulation, low crestfactor RF electrical signal waveform for deeper tissue penetration, andelectrical signal waveforms that promote efficient touch-up coagulation.In one aspect, the DDS circuit 4200 can create multiple wave shapelookup tables 4210 and during a tissue treatment procedure (e.g.,“on-the-fly” or in virtual real time based on user or sensor inputs)switch between different wave shapes stored in different lookup tables4210 based on the tissue effect desired and/or tissue feedback.

Accordingly, switching between wave shapes can be based on tissueimpedance and other factors, for example. In other aspects, the lookuptables 4210 can store electrical signal waveforms shaped to maximize thepower delivered into the tissue per cycle (i.e., trapezoidal or squarewave). In other aspects, the lookup tables 4210 can store wave shapessynchronized in such way that they make maximizing power delivery by anyone of the surgical instruments of surgical system 1000 when deliveringRF and ultrasonic drive signals. In yet other aspects, the lookup tables4210 can store electrical signal waveforms to drive ultrasonic and RFtherapeutic, and/or sub-therapeutic, energy simultaneously whilemaintaining ultrasonic frequency lock. Generally, the output wave shapemay be in the form of a sine wave, cosine wave, pulse wave, square wave,and the like. Nevertheless, the more complex and custom wave shapesspecific to different instruments and their tissue effects can be storedin the non-volatile memory of the generator circuit or in thenon-volatile memory (e.g., EEPROM) of the surgical instrument and befetched upon connecting the surgical instrument to the generatorcircuit. One example of a custom wave shape is an exponentially dampedsinusoid as used in many high crest factor “coagulation” waveforms, asshown in FIG. 36.

FIG. 36 illustrates one cycle of a discrete time digital electricalsignal waveform 4300, in accordance with at least one aspect of thepresent disclosure of an analog waveform 4304 (shown superimposed overthe discrete time digital electrical signal waveform 4300 for comparisonpurposes). The horizontal axis represents Time (t) and the vertical axisrepresents digital phase points. The digital electrical signal waveform4300 is a digital discrete time version of the desired analog waveform4304, for example. The digital electrical signal waveform 4300 isgenerated by storing an amplitude phase point 4302 that represents theamplitude per clock cycle T_(clk) over one cycle or period T_(o). Thedigital electrical signal waveform 4300 is generated over one periodT_(o) by any suitable digital processing circuit. The amplitude phasepoints are digital words stored in a memory circuit. In the exampleillustrated in FIGS. 41, 42, the digital word is a six-bit word that iscapable of storing the amplitude phase points with a resolution of 26 or64 bits. It will be appreciated that the examples shown in FIGS. 41, 42is for illustrative purposes and in actual implementations theresolution can be much higher. The digital amplitude phase points 4302over one cycle T_(o) are stored in the memory as a string of stringwords in a lookup table 4104, 4210 as described in connection with FIGS.41, 42, for example. To generate the analog version of the analogwaveform 4304, the amplitude phase points 4302 are read sequentiallyfrom the memory from 0 to T_(o) per clock cycle T_(clk) and areconverted by a DAC circuit 4108, 4212, also described in connection withFIGS. 41, 42. Additional cycles can be generated by repeatedly readingthe amplitude phase points 4302 of the digital electrical signalwaveform 4300 the from 0 to T_(o) for as many cycles or periods as maybe desired. The smooth analog version of the analog waveform 4304 isachieved by filtering the output of the DAC circuit 4108, 4212 by afilter 4112, 4214 (FIGS. 41 and 42). The filtered analog output signal4114, 4222 (FIGS. 41 and 42) is applied to the input of a poweramplifier.

FIG. 37 is a diagram of a control system 12950 configured to provideprogressive closure of a closure member (e.g., closure tube) when thedisplacement member advances distally and couples into a clamp arm(e.g., anvil) to lower the closure force load on the closure member at adesired rate and decrease the firing force load on the firing memberaccording to one aspect of this disclosure. In one aspect, the controlsystem 12950 may be implemented as a nested PID feedback controller. APID controller is a control loop feedback mechanism (controller) tocontinuously calculate an error value as the difference between adesired set point and a measured process variable and applies acorrection based on proportional, integral, and derivative terms(sometimes denoted P, I, and D respectively). The nested PID controllerfeedback control system 12950 includes a primary controller 12952, in aprimary (outer) feedback loop 12954 and a secondary controller 12955 ina secondary (inner) feedback loop 12956. The primary controller 12952may be a PID controller 12972 as shown in FIG. 38, and the secondarycontroller 12955 also may be a PID controller 12972 as shown in FIG. 38.The primary controller 12952 controls a primary process 12958 and thesecondary controller 12955 controls a secondary process 12960. Theoutput 12966 of the primary process 12958 is subtracted from a primaryset point SP₁ by a first summer 12962. The first summer 12962 produces asingle sum output signal which is applied to the primary controller12952. The output of the primary controller 12952 is the secondary setpoint SP₂. The output 12968 of the secondary process 12960 is subtractedfrom the secondary set point SP₂ by a second summer 12964.

In the context of controlling the displacement of a closure tube, thecontrol system 12950 may be configured such that the primary set pointSP₁ is a desired closure force value and the primary controller 12952 isconfigured to receive the closure force from a torque sensor coupled tothe output of a closure motor and determine a set point SP₂ motorvelocity for the closure motor. In other aspects, the closure force maybe measured with strain gauges, load cells, or other suitable forcesensors. The closure motor velocity set point SP₂ is compared to theactual velocity of the closure tube, which is determined by thesecondary controller 12955. The actual velocity of the closure tube maybe measured by comparing measuring the displacement of the closure tubewith the position sensor and measuring elapsed time with atimer/counter. Other techniques, such as linear or rotary encoders maybe employed to measure displacement of the closure tube. The output12968 of the secondary process 12960 is the actual velocity of theclosure tube. This closure tube velocity output 12968 is provided to theprimary process 12958 which determines the force acting on the closuretube and is fed back to the adder 12962, which subtracts the measuredclosure force from the primary set point SP₁. The primary set point SP₁may be an upper threshold or a lower threshold. Based on the output ofthe adder 12962, the primary controller 12952 controls the velocity anddirection of the closure motor. The secondary controller 12955 controlsthe velocity of the closure motor based on the actual velocity ofclosure tube measured by the secondary process 12960 and the secondaryset point SP₂, which is based on a comparison of the actual firing forceand the firing force upper and lower thresholds.

FIG. 38 illustrates a PID feedback control system 12970 according to oneaspect of this disclosure. The primary controller 12952 or the secondarycontroller 12955, or both, may be implemented as a PID controller 12972.In one aspect, the PID controller 12972 may comprise a proportionalelement 12974 (P), an integral element 12976 (I), and a derivativeelement 12978 (D). The outputs of the P, I, D elements 12974, 12976,12978 are summed by a summer 12986, which provides the control variableμ(t) to the process 12980. The output of the process 12980 is theprocess variable y(t). A summer 12984 calculates the difference betweena desired set point r(t) and a measured process variable y(t). The PIDcontroller 12972 continuously calculates an error value e(t) (e.g.,difference between closure force threshold and measured closure force)as the difference between a desired set point r(t) (e.g., closure forcethreshold) and a measured process variable y(t) (e.g., velocity anddirection of closure tube) and applies a correction based on theproportional, integral, and derivative terms calculated by theproportional element 12974 (P), integral element 12976 (I), andderivative element 12978 (D), respectively. The PID controller 12972attempts to minimize the error e(t) over time by adjustment of thecontrol variable μ(t) (e.g., velocity and direction of the closuretube).

In accordance with the PID algorithm, the “P” element 12974 accounts forpresent values of the error. For example, if the error is large andpositive, the control output will also be large and positive. Inaccordance with the present disclosure, the error term e(t) is thedifferent between the desired closure force and the measured closureforce of the closure tube. The “I” element 12976 accounts for pastvalues of the error. For example, if the current output is notsufficiently strong, the integral of the error will accumulate overtime, and the controller will respond by applying a stronger action. The“D” element 12978 accounts for possible future trends of the error,based on its current rate of change. For example, continuing the Pexample above, when the large positive control output succeeds inbringing the error closer to zero, it also puts the process on a path tolarge negative error in the near future. In this case, the derivativeturns negative and the D module reduces the strength of the action toprevent this overshoot.

It will be appreciated that other variables and set points may bemonitored and controlled in accordance with the feedback control systems12950, 12970. For example, the adaptive closure member velocity controlalgorithm described herein may measure at least two of the followingparameters: firing member stroke location, firing member load,displacement of cutting element, velocity of cutting element, closuretube stroke location, closure tube load, among others.

Ultrasonic surgical devices, such as ultrasonic scalpels, are findingincreasingly widespread applications in surgical procedures by virtue oftheir unique performance characteristics. Depending upon specific deviceconfigurations and operational parameters, ultrasonic surgical devicescan provide substantially simultaneous transection of tissue andhomeostasis by coagulation, desirably minimizing patient trauma. Anultrasonic surgical device may comprise a handpiece containing anultrasonic transducer, and an instrument coupled to the ultrasonictransducer having a distally-mounted end effector (e.g., a blade tip) tocut and seal tissue. In some cases, the instrument may be permanentlyaffixed to the handpiece. In other cases, the instrument may bedetachable from the handpiece, as in the case of a disposable instrumentor an interchangeable instrument. The end effector transmits ultrasonicenergy to tissue brought into contact with the end effector to realizecutting and sealing action. Ultrasonic surgical devices of this naturecan be configured for open surgical use, laparoscopic, or endoscopicsurgical procedures including robotic-assisted procedures.

Ultrasonic energy cuts and coagulates tissue using temperatures lowerthan those used in electrosurgical procedures and can be transmitted tothe end effector by an ultrasonic generator in communication with thehandpiece. Vibrating at high frequencies (e.g., 55,500 cycles persecond), the ultrasonic blade denatures protein in the tissue to form asticky coagulum. Pressure exerted on tissue by the blade surfacecollapses blood vessels and allows the coagulum to form a hemostaticseal. A surgeon can control the cutting speed and coagulation by theforce applied to the tissue by the end effector, the time over which theforce is applied, and the selected excursion level of the end effector.

The ultrasonic transducer may be modeled as an equivalent circuitcomprising a first branch having a static capacitance and a second“motional” branch having a serially connected inductance, resistance andcapacitance that define the electromechanical properties of a resonator.Known ultrasonic generators may include a tuning inductor for tuning outthe static capacitance at a resonant frequency so that substantially allof a generator's drive signal current flows into the motional branch.Accordingly, by using a tuning inductor, the generator's drive signalcurrent represents the motional branch current, and the generator isthus able to control its drive signal to maintain the ultrasonictransducer's resonant frequency. The tuning inductor may also transformthe phase impedance plot of the ultrasonic transducer to improve thegenerator's frequency lock capabilities. However, the tuning inductormust be matched with the specific static capacitance of an ultrasonictransducer at the operational resonant frequency. In other words, adifferent ultrasonic transducer having a different static capacitancerequires a different tuning inductor.

Additionally, in some ultrasonic generator architectures, thegenerator's drive signal exhibits asymmetrical harmonic distortion thatcomplicates impedance magnitude and phase measurements. For example, theaccuracy of impedance phase measurements may be reduced due to harmonicdistortion in the current and voltage signals.

Moreover, electromagnetic interference in noisy environments decreasesthe ability of the generator to maintain lock on the ultrasonictransducer's resonant frequency, increasing the likelihood of invalidcontrol algorithm inputs.

Electrosurgical devices for applying electrical energy to tissue inorder to treat and/or destroy the tissue are also finding increasinglywidespread applications in surgical procedures. An electrosurgicaldevice may comprise a handpiece and an instrument having adistally-mounted end effector (e.g., one or more electrodes). The endeffector can be positioned against the tissue such that electricalcurrent is introduced into the tissue. Electrosurgical devices can beconfigured for bipolar or monopolar operation. During bipolar operation,current is introduced into and returned from the tissue by active andreturn electrodes, respectively, of the end effector. During monopolaroperation, current is introduced into the tissue by an active electrodeof the end effector and returned through a return electrode (e.g., agrounding pad) separately located on a patient's body. Heat generated bythe current flowing through the tissue may form hemostatic seals withinthe tissue and/or between tissues and thus may be particularly usefulfor sealing blood vessels, for example. The end effector of anelectrosurgical device may also comprise a cutting member that ismovable relative to the tissue and the electrodes to transect thetissue.

Electrical energy applied by an electrosurgical device can betransmitted to the instrument by a generator in communication with thehandpiece. The electrical energy may be in the form of radio frequency(RF) energy. RF energy is a form of electrical energy that may be in thefrequency range of 300 kHz to 1 MHz, as described inEN60601-2-2:2009+A11:2011, Definition 201.3.218—HIGH FREQUENCY. Forexample, the frequencies in monopolar RF applications are typicallyrestricted to less than 5 MHz. However, in bipolar RF applications, thefrequency can be almost any value. Frequencies above 200 kHz aretypically used for monopolar applications in order to avoid the unwantedstimulation of nerves and muscles which would result from the use of lowfrequency current. Lower frequencies may be used for bipolar techniquesif a risk analysis shows the possibility of neuromuscular stimulationhas been mitigated to an acceptable level. Normally, frequencies above 5MHz are not used in order to minimize the problems associated with highfrequency leakage currents. It is generally recognized that 10 mA is thelower threshold of thermal effects on tissue.

During its operation, an electrosurgical device can transmit lowfrequency RF energy through tissue, which causes ionic agitation, orfriction, in effect resistive heating, thereby increasing thetemperature of the tissue. Because a sharp boundary may be createdbetween the affected tissue and the surrounding tissue, surgeons canoperate with a high level of precision and control, without sacrificingun-targeted adjacent tissue. The low operating temperatures of RF energymay be useful for removing, shrinking, or sculpting soft tissue whilesimultaneously sealing blood vessels. RF energy may work particularlywell on connective tissue, which is primarily comprised of collagen andshrinks when contacted by heat.

Due to their unique drive signal, sensing and feedback needs, ultrasonicand electrosurgical devices have generally required differentgenerators. Additionally, in cases where the instrument is disposable orinterchangeable with a handpiece, ultrasonic and electrosurgicalgenerators are limited in their ability to recognize the particularinstrument configuration being used and to optimize control anddiagnostic processes accordingly. Moreover, capacitive coupling betweenthe non-isolated and patient-isolated circuits of the generator,especially in cases where higher voltages and frequencies are used, mayresult in exposure of a patient to unacceptable levels of leakagecurrent.

Furthermore, due to their unique drive signal, sensing and feedbackneeds, ultrasonic and electrosurgical devices have generally requireddifferent user interfaces for the different generators. In suchconventional ultrasonic and electrosurgical devices, one user interfaceis configured for use with an ultrasonic instrument whereas a differentuser interface may be configured for use with an electrosurgicalinstrument. Such user interfaces include hand and/or foot activated userinterfaces such as hand activated switches and/or foot activatedswitches. As various aspects of combined generators for use with bothultrasonic and electrosurgical instruments are contemplated in thesubsequent disclosure, additional user interfaces that are configured tooperate with both ultrasonic and/or electrosurgical instrumentgenerators also are contemplated.

Additional user interfaces for providing feedback, whether to the useror other machine, are contemplated within the subsequent disclosure toprovide feedback indicating an operating mode or status of either anultrasonic and/or electrosurgical instrument. Providing user and/ormachine feedback for operating a combination ultrasonic and/orelectrosurgical instrument will require providing sensory feedback to auser and electrical/mechanical/electro-mechanical feedback to a machine.Feedback devices that incorporate visual feedback devices (e.g., an LCDdisplay screen, LED indicators), audio feedback devices (e.g., aspeaker, a buzzer) or tactile feedback devices (e.g., haptic actuators)for use in combined ultrasonic and/or electrosurgical instruments arecontemplated in the subsequent disclosure.

Other electrical surgical instruments include, without limitation,irreversible and/or reversible electroporation, and/or microwavetechnologies, among others. Accordingly, the techniques disclosed hereinare applicable to ultrasonic, bipolar or monopolar RF (electrosurgical),irreversible and/or reversible electroporation, and/or microwave basedsurgical instruments, among others.

Various aspects are directed to improved ultrasonic surgical devices,electrosurgical devices and generators for use therewith. Aspects of theultrasonic surgical devices can be configured for transecting and/orcoagulating tissue during surgical procedures, for example. Aspects ofthe electrosurgical devices can be configured for transecting,coagulating, scaling, welding and/or desiccating tissue during surgicalprocedures, for example.

Aspects of the generator utilize high-speed analog-to-digital sampling(e.g., approximately 200× oversampling, depending on frequency) of thegenerator drive signal current and voltage, along with digital signalprocessing, to provide a number of advantages and benefits over knowngenerator architectures. In one aspect, for example, based on currentand voltage feedback data, a value of the ultrasonic transducer staticcapacitance, and a value of the drive signal frequency, the generatormay determine the motional branch current of an ultrasonic transducer.This provides the benefit of a virtually tuned system, and simulates thepresence of a system that is tuned or resonant with any value of thestatic capacitance (e.g., C₀ in FIG. 22) at any frequency. Accordingly,control of the motional branch current may be realized by tuning out theeffects of the static capacitance without the need for a tuninginductor. Additionally, the elimination of the tuning inductor may notdegrade the generator's frequency lock capabilities, as frequency lockcan be realized by suitably processing the current and voltage feedbackdata.

High-speed analog-to-digital sampling of the generator drive signalcurrent and voltage, along with digital signal processing, may alsoenable precise digital filtering of the samples. For example, aspects ofthe generator may utilize a low-pass digital filter (e.g., a finiteimpulse response (FIR) filter) that rolls off between a fundamentaldrive signal frequency and a second-order harmonic to reduce theasymmetrical harmonic distortion and EMI-induced noise in current andvoltage feedback samples. The filtered current and voltage feedbacksamples represent substantially the fundamental drive signal frequency,thus enabling a more accurate impedance phase measurement with respectto the fundamental drive signal frequency and an improvement in thegenerator's ability to maintain resonant frequency lock. The accuracy ofthe impedance phase measurement may be further enhanced by averagingfalling edge and rising edge phase measurements, and by regulating themeasured impedance phase to 0°.

Various aspects of the generator may also utilize the high-speedanalog-to-digital sampling of the generator drive signal current andvoltage, along with digital signal processing, to determine real powerconsumption and other quantities with a high degree of precision. Thismay allow the generator to implement a number of useful algorithms, suchas, for example, controlling the amount of power delivered to tissue asthe impedance of the tissue changes and controlling the power deliveryto maintain a constant rate of tissue impedance increase. Some of thesealgorithms are used to determine the phase difference between thegenerator drive signal current and voltage signals. At resonance, thephase difference between the current and voltage signals is zero. Thephase changes as the ultrasonic system goes off-resonance. Variousalgorithms may be employed to detect the phase difference and adjust thedrive frequency until the ultrasonic system returns to resonance, i.e.,the phase difference between the current and voltage signals goes tozero. The phase information also may be used to infer the conditions ofthe ultrasonic blade. As discussed with particularity below, the phasechanges as a function of the temperature of the ultrasonic blade.Therefore, the phase information may be employed to control thetemperature of the ultrasonic blade. This may be done, for example, byreducing the power delivered to the ultrasonic blade when the ultrasonicblade runs too hot and increasing the power delivered to the ultrasonicblade when the ultrasonic blade runs too cold.

Various aspects of the generator may have a wide frequency range andincreased output power necessary to drive both ultrasonic surgicaldevices and electrosurgical devices. The lower voltage, higher currentdemand of electrosurgical devices may be met by a dedicated tap on awideband power transformer, thereby eliminating the need for a separatepower amplifier and output transformer. Moreover, sensing and feedbackcircuits of the generator may support a large dynamic range thataddresses the needs of both ultrasonic and electrosurgical applicationswith minimal distortion.

Various aspects may provide a simple, economical means for the generatorto read from, and optionally write to, a data circuit (e.g., asingle-wire bus device, such as a one-wire protocol EEPROM known underthe trade name “1-Wire”) disposed in an instrument attached to thehandpiece using existing multi-conductor generator/handpiece cables. Inthis way, the generator is able to retrieve and processinstrument-specific data from an instrument attached to the handpiece.This may enable the generator to provide better control and improveddiagnostics and error detection. Additionally, the ability of thegenerator to write data to the instrument makes possible newfunctionality in terms of, for example, tracking instrument usage andcapturing operational data. Moreover, the use of frequency band permitsthe backward compatibility of instruments containing a bus device withexisting generators.

Disclosed aspects of the generator provide active cancellation ofleakage current caused by unintended capacitive coupling betweennon-isolated and patient-isolated circuits of the generator. In additionto reducing patient risk, the reduction of leakage current may alsolessen electromagnetic emissions.

These and other benefits of aspects of the present disclosure will beapparent from the description to follow.

It will be appreciated that the terms “proximal” and “distal” are usedherein with reference to a clinician gripping a handpiece. Thus, an endeffector is distal with respect to the more proximal handpiece. It willbe further appreciated that, for convenience and clarity, spatial termssuch as “top” and “bottom” may also be used herein with respect to theclinician gripping the handpiece. However, surgical devices are used inmany orientations and positions, and these terms are not intended to belimiting and absolute.

FIG. 39 is an elevational exploded view of modular handheld ultrasonicsurgical instrument 6480 showing the left shell half removed from ahandle assembly 6482 exposing a device identifier communicativelycoupled to the multi-lead handle terminal assembly in accordance withone aspect of the present disclosure. In additional aspects of thepresent disclosure, an intelligent or smart battery is used to power themodular handheld ultrasonic surgical instrument 6480. However, the smartbattery is not limited to the modular handheld ultrasonic surgicalinstrument 6480 and, as will be explained, can be used in a variety ofdevices, which may or may not have power requirements (e.g., current andvoltage) that vary from one another. The smart battery assembly 6486, inaccordance with one aspect of the present disclosure, is advantageouslyable to identify the particular device to which it is electricallycoupled. It does this through encrypted or unencrypted identificationmethods. For instance, a smart battery assembly 6486 can have aconnection portion, such as connection portion 6488. The handle assembly6482 can also be provided with a device identifier communicativelycoupled to the multi-lead handle terminal assembly 6491 and operable tocommunicate at least one piece of information about the handle assembly6482. This information can pertain to the number of times the handleassembly 6482 has been used, the number of times an ultrasonictransducer/generator assembly 6484 (presently disconnected from thehandle assembly 6482) has been used, the number of times a waveguideshaft assembly 6490 (presently connected to the handle assembly 6482)has been used, the type of the waveguide shaft assembly 6490 that ispresently connected to the handle assembly 6482, the type or identity ofthe ultrasonic transducer/generator assembly 6484 that is presentlyconnected to the handle assembly 6482, and/or many othercharacteristics. When the smart battery assembly 6486 is inserted in thehandle assembly 6482, the connection portion 6488 within the smartbattery assembly 6486 makes communicating contact with the deviceidentifier of the handle assembly 6482. The handle assembly 6482,through hardware, software, or a combination thereof, is able totransmit information to the smart battery assembly 6486 (whether byself-initiation or in response to a request from the smart batteryassembly 6486). This communicated identifier is received by theconnection portion 6488 of the smart battery assembly 6486. In oneaspect, once the smart battery assembly 6486 receives the information,the communication portion is operable to control the output of the smartbattery assembly 6486 to comply with the device's specific powerrequirements.

In one aspect, the communication portion includes a processor 6493 and amemory 6497, which may be separate or a single component. The processor6493, in combination with the memory, is able to provide intelligentpower management for the modular handheld ultrasonic surgical instrument6480. This aspect is particularly advantageous because an ultrasonicdevice, such as the modular handheld ultrasonic surgical instrument6480, has a power requirement (frequency, current, and voltage) that maybe unique to the modular handheld ultrasonic surgical instrument 6480.In fact, the modular handheld ultrasonic surgical instrument 6480 mayhave a particular power requirement or limitation for one dimension ortype of outer tube 6494 and a second different power requirement for asecond type of waveguide having a different dimension, shape, and/orconfiguration.

A smart battery assembly 6486, in accordance with at least one aspect ofthe present disclosure, therefore, allows a battery assembly to be usedamongst several surgical instruments. Because the smart battery assembly6486 is able to identify to which device it is attached and is able toalter its output accordingly, the operators of various differentsurgical instruments utilizing the smart battery assembly 6486 no longerneed be concerned about which power source they are attempting toinstall within the electronic device being used. This is particularlyadvantageous in an operating environment where a battery assembly needsto be replaced or interchanged with another surgical instrument in themiddle of a complex surgical procedure.

In a further aspect of the present disclosure, the smart batteryassembly 6486 stores in a memory 6497 a record of each time a particulardevice is used. This record can be useful for assessing the end of adevice's useful or permitted life. For instance, once a device is used20 times, such batteries in the smart battery assembly 6486 connected tothe device will refuse to supply power thereto—because the device isdefined as a “no longer reliable” surgical instrument. Reliability isdetermined based on a number of factors. One factor can be wear, whichcan be estimated in a number of ways including the number of times thedevice has been used or activated. After a certain number of uses, theparts of the device can become worn and tolerances between partsexceeded. For instance, the smart battery assembly 6486 can sense thenumber of button pushes received by the handle assembly 6482 and candetermine when a maximum number of button pushes has been met orexceeded. The smart battery assembly 6486 can also monitor an impedanceof the button mechanism which can change, for instance, if the handlegets contaminated, for example, with saline.

This wear can lead to an unacceptable failure during a procedure. Insome aspects, the smart battery assembly 6486 can recognize which partsare combined together in a device and even how many uses a part hasexperienced. For instance, if the smart battery assembly 6486 is a smartbattery according to the present disclosure, it can identify the handleassembly 6482, the waveguide shaft assembly 6490, as well as theultrasonic transducer/generator assembly 6484, well before the userattempts use of the composite device. The memory 6497 within the smartbattery assembly 6486 can, for example, record a time when theultrasonic transducer/generator assembly 6484 is operated, and how,when, and for how long it is operated. If the ultrasonictransducer/generator assembly 6484 has an individual identifier, thesmart battery assembly 6486 can keep track of uses of the ultrasonictransducer/generator assembly 6484 and refuse to supply power to thatthe ultrasonic transducer/generator assembly 6484 once the handleassembly 6482 or the ultrasonic transducer/generator assembly 6484exceeds its maximum number of uses. The ultrasonic transducer/generatorassembly 6484, the handle assembly 6482, the waveguide shaft assembly6490, or other components can include a memory chip that records thisinformation as well. In this way, any number of smart batteries in thesmart battery assembly 6486 can be used with any number of ultrasonictransducer/generator assemblies 6484, staplers, vessel sealers, etc. andstill be able to determine the total number of uses, or the total timeof use (through use of the clock), or the total number of actuations,etc. of the ultrasonic transducer/generator assembly 6484, the stapler,the vessel sealer, etc. or charge or discharge cycles. Smartfunctionality may reside outside the battery assembly 6486 and mayreside in the handle assembly 6482, the ultrasonic transducer/generatorassembly 6484, and/or the shaft assembly 6490, for example.

When counting uses of the ultrasonic transducer/generator assembly 6484,to intelligently terminate the life of the ultrasonictransducer/generator assembly 6484, the surgical instrument accuratelydistinguishes between completion of an actual use of the ultrasonictransducer/generator assembly 6484 in a surgical procedure and amomentary lapse in actuation of the ultrasonic transducer/generatorassembly 6484 due to, for example, a battery change or a temporary delayin the surgical procedure. Therefore, as an alternative to simplycounting the number of activations of the ultrasonictransducer/generator assembly 6484, a real-time clock (RTC) circuit canbe implemented to keep track of the amount of time the ultrasonictransducer/generator assembly 6484 actually is shut down. From thelength of time measured, it can be determined through appropriate logicif the shutdown was significant enough to be considered the end of oneactual use or if the shutdown was too short in time to be considered theend of one use. Thus, in some applications, this method may be a moreaccurate determination of the useful life of the ultrasonictransducer/generator assembly 6484 than a simple “activations-based”algorithm, which for example, may provide that ten “activations” occurin a surgical procedure and, therefore, ten activations should indicatethat the counter is incremented by one. Generally, this type and systemof internal clocking will prevent misuse of the device that is designedto deceive a simple “activations-based” algorithm and will preventincorrect logging of a complete use in instances when there was only asimple de-mating of the ultrasonic transducer/generator assembly 6484 orthe smart battery assembly 6486 that was required for legitimatereasons.

Although the ultrasonic transducer/generator assemblies 6484 of thesurgical instrument 6480 are reusable, in one aspect a finite number ofuses may be set because the surgical instrument 6480 is subjected toharsh conditions during cleaning and sterilization. More specifically,the battery pack is configured to be sterilized. Regardless of thematerial employed for the outer surfaces, there is a limited expectedlife for the actual materials used. This life is determined by variouscharacteristics which could include, for example, the amount of timesthe pack has actually been sterilized, the time from which the pack wasmanufactured, and the number of times the pack has been recharged, toname a few. Also, the life of the battery cells themselves is limited.Software of the present disclosure incorporates inventive algorithmsthat verify the number of uses of the ultrasonic transducer/generatorassembly 6484 and smart battery assembly 6486 and disables the devicewhen this number of uses has been reached or exceeded. Analysis of thebattery pack exterior in each of the possible sterilizing methods can beperformed. Based on the harshest sterilization procedure, a maximumnumber of permitted sterilizations can be defined and that number can bestored in a memory of the smart battery assembly 6486. If it is assumedthat a charger is non-sterile and that the smart battery assembly 6486is to be used after it is charged, then the charge count can be definedas being equal to the number of sterilizations encountered by thatparticular pack.

In one aspect, the hardware in the battery pack may be to disabled tominimize or eliminate safety concerns due to continuous drain in fromthe battery cells after the pack has been disabled by software. Asituation can exist where the battery's internal hardware is incapableof disabling the battery under certain low voltage conditions. In such asituation, in an aspect, the charger can be used to “kill” the battery.Due to the fact that the battery microcontroller is OFF while thebattery is in its charger, a non-volatile, System Management Bus (SMB)based electrically erasable programmable read only memory (EEPROM) canbe used to exchange information between the battery microcontroller andthe charger. Thus, a serial EEPROM can be used to store information thatcan be written and read even when the battery microcontroller is OFF,which is very beneficial when trying to exchange information with thecharger or other peripheral devices. This example EEPROM can beconfigured to contain enough memory registers to store at least (a) ause-count limit at which point the battery should be disabled (BatteryUse Count), (b) the number of procedures the battery has undergone(Battery Procedure Count), and/or (c) a number of charges the batteryhas undergone (Charge Count), to name a few. Some of the informationstored in the EEPROM, such as the Use Count Register and Charge CountRegister are stored in write-protected sections of the EEPROM to preventusers from altering the information. In an aspect, the use and countersare stored with corresponding bit-inverted minor registers to detectdata corruption.

Any residual voltage in the SMBus lines could damage the microcontrollerand corrupt the SMBus signal. Therefore, to ensure that the SMBus linesof a battery controller do not carry a voltage while the microcontrolleris OFF, relays are provided between the external SM Bus lines and thebattery microcontroller board.

During charging of the smart battery assembly 6486, an “end-of-charge”condition of the batteries within the smart battery assembly 6486 isdetermined when, for example, the current flowing into the battery fallsbelow a given threshold in a tapering manner when employing aconstant-current/constant-voltage charging scheme. To accurately detectthis “end-of-charge” condition, the battery microcontroller and buckboards are powered down and turned OFF during charging of the battery toreduce any current drain that may be caused by the boards and that mayinterfere with the tapering current detection. Additionally, themicrocontroller and buck boards are powered down during charging toprevent any resulting corruption of the SM Bus signal.

With regard to the charger, in one aspect the smart battery assembly6486 is prevented from being inserted into the charger in any way otherthan the correct insertion position. Accordingly, the exterior of thesmart battery assembly 6486 is provided with charger-holding features. Acup for holding the smart battery assembly 6486 securely in the chargeris configured with a contour-matching taper geometry to prevent theaccidental insertion of the smart battery assembly 6486 in any way otherthan the correct (intended) way. It is further contemplated that thepresence of the smart battery assembly 6486 may be detectable by thecharger itself. For example, the charger may be configured to detect thepresence of the SMBus transmission from the battery protection circuit,as well as resistors that are located in the protection board. In suchcase, the charger would be enabled to control the voltage that isexposed at the charger's pins until the smart battery assembly 6486 iscorrectly seated or in place at the charger. This is because an exposedvoltage at the charger's pins would present a hazard and a risk that anelectrical short could occur across the pins and cause the charger toinadvertently begin charging.

In some aspects, the smart battery assembly 6486 can communicate to theuser through audio and/or visual feedback. For example, the smartbattery assembly 6486 can cause the LEDs to light in a pre-set way. Insuch a case, even though the microcontroller in the ultrasonictransducer/generator assembly 6484 controls the LEDs, themicrocontroller receives instructions to be carried out directly fromthe smart battery assembly 6486.

In yet a further aspect of the present disclosure, the microcontrollerin the ultrasonic transducer/generator assembly 6484, when not in usefor a predetermined period of time, goes into a sleep mode.Advantageously, when in the sleep mode, the clock speed of themicrocontroller is reduced, cutting the current drain significantly.Some current continues to be consumed because the processor continuespinging waiting to sense an input. Advantageously, when themicrocontroller is in this power-saving sleep mode, the microcontrollerand the battery controller can directly control the LEDs. For example, adecoder circuit could be built into the ultrasonic transducer/generatorassembly 6484 and connected to the communication lines such that theLEDs can be controlled independently by the processor 6493 while theultrasonic transducer/generator assembly 6484 microcontroller is “OFF”or in a “sleep mode.” This is a power-saving feature that eliminates theneed for waking up the microcontroller in the ultrasonictransducer/generator assembly 6484. Power is conserved by allowing thegenerator to be turned off while still being able to actively controlthe user-interface indicators.

Another aspect slows down one or more of the microcontrollers toconserve power when not in use. For example, the clock frequencies ofboth microcontrollers can be reduced to save power. To maintainsynchronized operation, the microcontrollers coordinate the changing oftheir respective clock frequencies to occur at about the same time, boththe reduction and, then, the subsequent increase in frequency when fullspeed operation is required. For example, when entering the idle mode,the clock frequencies are decreased and, when exiting the idle mode, thefrequencies are increased.

In an additional aspect, the smart battery assembly 6486 is able todetermine the amount of usable power left within its cells and isprogrammed to only operate the surgical instrument to which it isattached if it determines there is enough battery power remaining topredictably operate the device throughout the anticipated procedure. Forexample, the smart battery assembly 6486 is able to remain in anon-operational state if there is not enough power within the cells tooperate the surgical instrument for 20 seconds. According to one aspect,the smart battery assembly 6486 determines the amount of power remainingwithin the cells at the end of its most recent preceding function, e.g.,a surgical cutting. In this aspect, therefore, the smart batteryassembly 6486 would not allow a subsequent function to be carried outif, for example, during that procedure, it determines that the cellshave insufficient power. Alternatively, if the smart battery assembly6486 determines that there is sufficient power for a subsequentprocedure and goes below that threshold during the procedure, it wouldnot interrupt the ongoing procedure and, instead, will allow it tofinish and thereafter prevent additional procedures from occurring.

The following explains an advantage to maximizing use of the device withthe smart battery assembly 6486 of the present disclosure. In thisexample, a set of different devices have different ultrasonictransmission waveguides. By definition, the waveguides could have arespective maximum allowable power limit where exceeding that powerlimit overstresses the waveguide and eventually causes it to fracture.One waveguide from the set of waveguides will naturally have thesmallest maximum power tolerance. Because prior-art batteries lackintelligent battery power management, the output of prior-art batteriesmust be limited by a value of the smallest maximum allowable power inputfor the smallest/thinnest/most-frail waveguide in the set that isenvisioned to be used with the device/battery. This would be true eventhough larger, thicker waveguides could later be attached to that handleand, by definition, allow a greater force to be applied. This limitationis also true for maximum battery power. For example, if one battery isdesigned to be used in multiple devices, its maximum output power willbe limited to the lowest maximum power rating of any of the devices inwhich it is to be used. With such a configuration, one or more devicesor device configurations would not be able to maximize use of thebattery because the battery does not know the particular device'sspecific limits.

In one aspect, the smart battery assembly 6486 may be employed tointelligently circumvent the above-mentioned ultrasonic devicelimitations. The smart battery assembly 6486 can produce one output forone device or a particular device configuration and the same smartbattery assembly 6486 can later produce a different output for a seconddevice or device configuration. This universal smart battery surgicalsystem lends itself well to the modern operating room where space andtime are at a premium. By having a smart battery pack operate manydifferent devices, the nurses can easily manage the storage, retrieval,and inventory of these packs. Advantageously, in one aspect the smartbattery system according to the present disclosure may employ one typeof charging station, thus increasing ease and efficiency of use anddecreasing cost of surgical room charging equipment.

In addition, other surgical instruments, such as an electric stapler,may have a different power requirement than that of the modular handheldultrasonic surgical instrument 6480. In accordance with various aspectsof the present disclosure, a smart battery assembly 6486 can be usedwith any one of a series of surgical instruments and can be made totailor its own power output to the particular device in which it isinstalled. In one aspect, this power tailoring is performed bycontrolling the duty cycle of a switched mode power supply, such asbuck, buck-boost, boost, or other configuration, integral with orotherwise coupled to and controlled by the smart battery assembly 6486.In other aspects, the smart battery assembly 6486 can dynamically changeits power output during device operation. For instance, in vesselsealing devices, power management provides improved tissue sealing. Inthese devices, large constant current values are needed. The total poweroutput needs to be adjusted dynamically because, as the tissue issealed, its impedance changes. Aspects of the present disclosure providethe smart battery assembly 6486 with a variable maximum current limit.The current limit can vary from one application (or device) to another,based on the requirements of the application or device.

FIG. 40 is a detail view of a trigger 6483 portion and switch of theultrasonic surgical instrument 6480 shown in FIG. 39, in accordance withat least one aspect of the present disclosure. The trigger 6483 isoperably coupled to the jaw member 6495 of the end effector 6492. Theultrasonic blade 6496 is energized by the ultrasonictransducer/generator assembly 6484 upon activating the activation switch6485. Continuing now with FIG. 39 and also looking to FIG. 40, thetrigger 6483 and the activation switch 6485 are shown as components ofthe handle assembly 6482. The trigger 6483 activates the end effector6492, which has a cooperative association with the ultrasonic blade 6496of the waveguide shaft assembly 6490 to enable various kinds of contactbetween the end effector jaw member 6495 and the ultrasonic blade 6496with tissue and/or other substances. The jaw member 6495 of the endeffector 6492 is usually a pivoting jaw that acts to grasp or clamp ontotissue disposed between the jaw and the ultrasonic blade 6496. In oneaspect, an audible feedback is provided in the trigger that clicks whenthe trigger is fully depressed. The noise can be generated by a thinmetal part that the trigger snaps over while closing. This feature addsan audible component to user feedback that informs the user that the jawis fully compressed against the waveguide and that sufficient clampingpressure is being applied to accomplish vessel sealing. In anotheraspect, force sensors such as strain gages or pressure sensors may becoupled to the trigger 6483 to measure the force applied to the trigger6483 by the user. In another aspect, force sensors such as strain gagesor pressure sensors may be coupled to the switch 6485 button such thatdisplacement intensity corresponds to the force applied by the user tothe switch 6485 button.

The activation switch 6485, when depressed, places the modular handheldultrasonic surgical instrument 6480 into an ultrasonic operating mode,which causes ultrasonic motion at the waveguide shaft assembly 6490. Inone aspect, depression of the activation switch 6485 causes electricalcontacts within a switch to close, thereby completing a circuit betweenthe smart battery assembly 6486 and the ultrasonic transducer/generatorassembly 6484 so that electrical power is applied to the ultrasonictransducer, as previously described. In another aspect, depression ofthe activation switch 6485 closes electrical contacts to the smartbattery assembly 6486. Of course, the description of closing electricalcontacts in a circuit is, here, merely an example general description ofswitch operation. There are many alternative aspects that can includeopening contacts or processor-controlled power delivery that receivesinformation from the switch and directs a corresponding circuit reactionbased on the information.

FIG. 41 is a fragmentary, enlarged perspective view of an end effector6492, in accordance with at least one aspect of the present disclosure,from a distal end with a jaw member 6495 in an open position. Referringto FIG. 41, a perspective partial view of the distal end 6498 of thewaveguide shaft assembly 6490 is shown. The waveguide shaft assembly6490 includes an outer tube 6494 surrounding a portion of the waveguide.The ultrasonic blade 6496 portion of the waveguide 6499 protrudes fromthe distal end 6498 of the outer tube 6494. It is the ultrasonic blade6496 portion that contacts the tissue during a medical procedure andtransfers its ultrasonic energy to the tissue. The waveguide shaftassembly 6490 also includes a jaw member 6495 that is coupled to theouter tube 6494 and an inner tube (not visible in this view). The jawmember 6495, together with the inner and outer tubes and the ultrasonicblade 6496 portion of the waveguide 6499, can be referred to as an endeffector 6492. As will be explained below, the outer tube 6494 and thenon-illustrated inner tube slide longitudinally with respect to eachother. As the relative movement between the outer tube 6494 and thenon-illustrated inner tube occurs, the jaw member 6495 pivots upon apivot point, thereby causing the jaw member 6495 to open and close. Whenclosed, the jaw member 6495 imparts a pinching force on tissue locatedbetween the jaw member 6495 and the ultrasonic blade 6496, insuringpositive and efficient blade-to-tissue contact.

Turning now to FIG. 42, the end effector 8400 comprises RF data sensors8406, 8408 a, 8408 b located on the jaw member 8402. The end effector8400 comprises a jaw member 8402 and an ultrasonic blade 8404. The jawmember 8402 is shown clamping tissue 8410 located between the jaw member8402 and the ultrasonic blade 8404. A first sensor 8406 is located in acenter portion of the jaw member 8402. Second and third sensors 8408 a,8408 b are located on lateral portions of the jaw member 8402. Thesensors 8406, 8408 a, 8408 b are mounted or formed integrally with aflexible circuit 8412 (shown more particularly in FIG. 52) configured tobe fixedly mounted to the jaw member 8402.

The end effector 8400 is an example end effector for a surgicalinstrument. The sensors 8406, 8408 a, 8408 b are electrically connectedto a control circuit such as the control circuit 7400 (FIG. 63) viainterface circuits. The sensors 8406, 8408 a, 8408 b are battery poweredand the signals generated by the sensors 8406, 8408 a, 8408 b areprovided to analog and/or digital processing circuits of the controlcircuit.

In one aspect, the first sensor 8406 is a force sensor to measure anormal force F3 applied to the tissue 8410 by the jaw member 8402. Thesecond and third sensors 8408 a, 8408 b include one or more elements toapply RF energy to the tissue 8410, measure tissue impedance, down forceF1, transverse forces F2, and temperature, among other parameters.Electrodes 8409 a, 8409 b are electrically coupled to an energy sourceand apply RF energy to the tissue 8410. In one aspect, the first sensor8406 and the second and third sensors 8408 a, 8408 b are strain gaugesto measure force or force per unit area. It will be appreciated that themeasurements of the down force F1, the lateral forces F2, and the normalforce F3 may be readily converted to pressure by determining the surfacearea upon which the force sensors 8406, 8408 a, 8408 b are acting upon.Additionally, as described with particularity herein, the flexiblecircuit 8412 may comprise temperature sensors embedded in one or morelayers of the flexible circuit 8412. The one or more temperature sensorsmay be arranged symmetrically or asymmetrically and provide tissue 8410temperature feedback to control circuits of an ultrasonic drive circuitand an RF drive circuit.

Ultrasonic spectroscopy smart blade algorithm techniques may be employedfor estimating the state of the jaw (clamp arm pad burn through,staples, broken blade, bone in jaw, tissue in jaw, back-cutting with jawclosed, etc.) based on the impedance

${Z_{g}(t)} = \frac{V_{g}(t)}{I_{g}(t)}$of an ultrasonic transducer configured to drive an ultrasonic transducerblade, in accordance with at least one aspect of the present disclosure.The impedance Z_(g)(t), magnitude |Z|, and phase φ are plotted as afunction of frequency f.

Dynamic mechanical analysis (DMA), also known as dynamic mechanicalspectroscopy or simply mechanical spectroscopy, is a technique used tostudy and characterize materials. A sinusoidal stress is applied to amaterial, and the strain in the material is measured, allowing thedetermination of the complex modulus of the material. The spectroscopyas applied to ultrasonic devices includes exciting the tip of theultrasonic blade with a sweep of frequencies (compound signals ortraditional frequency sweeps) and measuring the resulting compleximpedance at each frequency. The complex impedance measurements of theultrasonic transducer across a range of frequencies are used in aclassifier or model to infer the characteristics of the ultrasonic endeffector. In one aspect, the present disclosure provides a technique fordetermining the state of an ultrasonic end effector (clamp arm, jaw) todrive automation in the ultrasonic device (such as disabling power toprotect the device, executing adaptive algorithms, retrievinginformation, identifying tissue, etc.).

FIG. 43 is a spectra 132030 of an ultrasonic device with a variety ofdifferent states and conditions of the end effector where the impedanceZ_(g)(t), magnitude |Z|, and phase φ are plotted as a function offrequency f, in accordance with at least one aspect of the presentdisclosure. The spectra 132030 is plotted in three-dimensional spacewhere frequency (Hz) is plotted along the x-axis, phase (Rad) is plottedalong the y-axis, and magnitude (Ohms) is plotted along the z-axis.

Spectral analysis of different jaw bites and device states producesdifferent complex impedance characteristic patterns (fingerprints)across a range of frequencies for different conditions and states. Eachstate or condition has a different characteristic pattern in 3D spacewhen plotted. These characteristic patterns can be used to estimate thecondition and state of the end effector. FIG. 43 shows the spectra forair 132032, clamp arm pad 132034, chamois 132036, staple 132038, andbroken blade 132040. The chamois 132036 may be used to characterizedifferent types of tissue.

The spectra 132030 can be evaluated by applying a low-power electricalsignal across the ultrasonic transducer to produce a non-therapeuticexcitation of the ultrasonic blade. The low-power electrical signal canbe applied in the form of a sweep or a compound Fourier series tomeasure the impedance

${Z_{g}(t)} = \frac{V_{g}(t)}{I_{g}(t)}$across the ultrasonic transducer at a range of frequencies in series(sweep) or in parallel (compound signal) using an FFT.

FIG. 44 is a graphical representation of a plot 132042 of a set of 3Dtraining data set (S), where ultrasonic transducer impedance Z_(g)(t),magnitude |Z|, and phase φ are plotted as a function of frequency f, inaccordance with at least one aspect of the present disclosure. The 3Dtraining data set (S) plot 132042 is graphically depicted inthree-dimensional space where phase (Rad) is plotted along the x-axis,frequency (Hz) is plotted along the y-axis, magnitude (Ohms) is plottedalong the z-axis, and a parametric Fourier series is fit to the 3Dtraining data set (S). A methodology for classifying data is based onthe 3D training data set (S0 is used to generate the plot 132042).

The parametric Fourier series fit to the 3D training data set (S) isgiven by:

$\overset{\rightharpoonup}{p} = {{\overset{\rightharpoonup}{a}}_{0} + {\sum\limits_{n = 1}^{\infty}\left( {{{\overset{\rightharpoonup}{a}}_{n}\cos\frac{n\;\pi\; t}{L}} + {{\overset{\rightharpoonup}{b}}_{n}\sin\frac{n\;\pi\; t}{L}}} \right)}}$

For a new point

, the perpendicular distance from

to

is found by:

$D = {{\overset{\rightharpoonup}{p} - \overset{\rightharpoonup}{z}}}$When: $\frac{\partial D}{\partial T} = 0$ Then: D = D_(⊥)

A probability distribution of D can be used to estimate the probabilityof a data point

belonging to the group S.

Adjustment of Compression Force Applied to Tissue Based on Proportion ofEnergy Modalities

Aspects of the present disclosure are presented for a surgicalinstrument that is situationally aware. The surgical instrument may beany suitable surgical instrument described in the present disclosure.For the sake of clarity, surgical instrument 112 is referenced. Inparticular, the surgical instrument 112 may be a bipolar combinationsurgical instrument 112 which may automatically adjust a compressionforce applied by the end effector of the surgical instrument 112 basedon a selected energy modality. In one aspect, the bipolar combinationsurgical instrument 112 may be configured to deliver energy according toa bipolar radio frequency (RF) and an ultrasonic energy modality. Morespecifically, the automatic adjustment may be based on a proportion oftwo different selected energy modalities. This automatic adjustment ofthe compression force is an example of a situational awarenesscharacteristic of the surgical instrument 112 that may improve theefficacy and quality of a surgical procedure performed with the surgicalinstrument 112. The clamp pressure applied by the end effector can beindicative of the compression force applied to tissue being treated. Asdiscussed above, selectable energy modalities include ultrasonic,bipolar or monopolar radio frequency (electrosurgical), irreversible orreversible electroporation, and microwave energy modality implemented bya generator of the surgical instrument 112. In one aspect, the twoselected energy modalities are bipolar RF energy and ultrasonic energy.Additionally or alternatively to adjusting the compression force appliedto tissue based on the selected energy modality, the compression forcemay also be adjusted based on a power parameter. The power parameter mayrefer to the relative proportion of total energy applied during asurgical procedure that is allocated between bipolar RF and ultrasonicenergy, respectively, for example.

In general, the compression force adjustment may be actively performedduring performance of a surgical procedure. Such active adjustment canmean that the clinician operating the surgical instrument 112 does notneed to manually adjust the clamp arm, waveguide or ultrasonic blade, orend effector to modify the compression force applied to tissue beingtreated in the jaws of the end effector. As described below in furtherdetail, a control circuit or generator of the situationally awaresurgical instrument 112 may automatically adjust tissue compressionforce by executing an algorithm. The algorithm is executable todetermine an appropriate compression force by considering the particularproportion or blend of the selected energy modalities. For example, therelative proportion of time spent applying each energy modality can beconsidered in determining suitable tissue compression forces to beapplied during the course of the performed surgical procedure. Therelative amplitudes of each energy modality could be considered as well.Also, each type of energy modality can correspond to a certain pressureor range of pressures, which could also change depending on otherparameters such as the power and timing of the delivered energymodality. This energy-pressure relationship can also be understood asenergy delivered and pressure existing on a spectrum together. That is,the more compression pressure that is applied, the more effective theapplication of energy to treat tissue will be. Consequently, less energymay be required when more compression pressure is applied. Energy isdelivered according to the selected energy modality.

The selected energy modalities could be applied simultaneously totissue. Alternatively, the generator may switch between providing adrive output signal according to a first energy modality such as bipolarRF and providing the drive output signal according to a second energymodality such as ultrasonic. That is, the delivery of RF can followultrasonic and vice versa. The extent of switching may be used in thealgorithm to determine a suitable automatic adjustment to tissuecompression force. For example, when the generator switches fromdelivering ultrasonic energy to bipolar RF energy, the applied tissuecompression force may be increased. When multiple energy modalities areapplied simultaneously, the relative proportion of the energy modalitiesmay be used to determine the compression force adjustment. For example,the control circuit could the proportion of ultrasonic drive signals toRF drive signals provided by the generator. As described further below,electrical or mechanical methods of adjusting tissue compression may beused and such methods may or may not involve control by the processor,control circuit, or generator as appropriate. In some aspects, thetissue compression adjustment algorithm may be stored in memory and maybe updated by an algorithm program update transmitted from thecorresponding surgical hub (e.g., surgical hub 106, 206) to the surgicalinstrument 112. In turn, the hub may receive this algorithm programupdate from a cloud computing system (e.g. cloud 104, 204). The hub mayalso store the update locally in a memory device of the hub.Additionally or alternatively, the control circuit or generator of thesurgical instrument 112 can modify the algorithm as suitable, such as bya clinician changing the parameters of the algorithm through a userinterface of the surgical instrument 112.

Mechanical methods of adjusting tissue compression force includeadjusting the waveguide or ultrasonic blade and adjusting the clamp armlinkage mechanism (e.g., linkage components of the transmissions 706a-706 e) of the surgical instrument 112. The ultrasonic blade can be forexample, an offset oval ultrasonic blade where the end effector clamparm and offset ultrasonic blade are rotatable relative to each other todefine a tissue gap distance between the end effector jaws. By adjustingthe tissue gap distance, various tissue compression forces are possible.In this way, the ultrasonic blade is adjustable to generate a smallertissue gap (and thus relatively higher compression force) when the RFenergy modality is selected and to generate a larger tissue gap (andthus relatively lower compression force) when the ultrasonic energymodality is selected. The end effector jaw members can also be adjustedfor a desired tissue gap size independently of the wave guide. Forexample, in one aspect, a clamp arm linkage mechanism is provided tochange the clamp arm actuator rod stroke according to the selectedenergy modality. The clamp arm actuator rod (e.g., articulation actuatorsuch as via output shaft of the motor 704 a, 704 b coupled to moveablemechanical elements of transmissions 706 a, 706 b) is coupled to alinkage pivot, which in turn is operationally coupled to a mechanicalselector of a surgical instrument 112.

The mechanical selector may be a mechanically actuated switch such as amomentary-action manual switch, mechanical-bail switch, capacitive touchswitch, membrane switch, or other suitable mechanical switch. Themechanical switch may be controlled by the control circuit or generatorto change the linkage pivot or linkage mechanism coupled to the endeffector clamp arm such that the clamp arm exerts different compressionforce according to the selected energy modality. As such, in oneposition of the mechanical switch, the clamp arm may be linked so thatwhen the actuator rod is actuated, relatively high compressive forcesare applied. In a second position of the mechanical switch, the clamparm may be linked so that when the actuator rod is actuated, relativelylow compressive forces are applied. In one aspect, the first positioncorresponds to the ultrasonic energy modality, while the second positioncorresponds to the bipolar RF energy modality.

Electrical methods of adjusting tissue compression force are alsopossible. For example, compression force can be automatically adjustedby the situationally aware surgical instrument 112 with the use of anelectroactive polymer (EAP). The EAP can be, for example an electric EAP(e.g., ferroelectric polymer), ionic EAP (e.g., ionomeric polymer-metalcomposite), non-ionic EAP, conductive polymer or other suitable EAP. TheEAP can be arranged in parallel with an RF energy circuit of thesurgical instrument 112, where the RF energy circuit is configured toimplement the delivery of RF energy. Accordingly, the selection of an RFenergy modality would cause current to flow through the RF energycircuit as RF energy is being delivered, which would also cause the EAPto expand. Upon expansion of the EAP, the tissue gap size decreases andresults in the application of greater compression force.

Additionally or alternatively, multiple sets of electrodes (e.g.electrodes 796, 3074 a, 3074 b) may be provided and activated accordingto a particular sequence. This type of surgical treatment can be calledhybrid activation. In hybrid activation, multiple different electrodesin the end effector are provided to perform different surgicalfunctions. For example, a first set of electrodes may be used for thesealing surgical stage and a second set of electrodes may be used forthe cutting surgical stage. To this end, a switch, filter, or othersuitable wiring is provided to route the drive signal delivered by thegenerator to one or more appropriate electrodes in the end effector. Forexample, the situationally aware surgical instrument 112 may determinethat an end effector electrode is configured for sealing rather thancutting. Consequently, an RF drive signal of relatively low voltage andhigh current may be driven through the output port of the generator tothe pre-defined sealing electrodes for sealing. Similarly, an RF drivesignal of greater power than the one used for sealing may be driven todifferent pre-defined cutting electrodes. The surgical instrument 112may determine when the shift from the sealing electrodes to the cuttingelectrodes should occur based on a measured impedance threshold. Whenthe impedance threshold is reached, the surgical instrument 112 maydetermine that a sufficiently secure seal has been created and that thecutting stage of the surgical procedure may begin. In general, the drivesignal from the generator output port is routed appropriately to thecorresponding electrode. Thus, drive signals can be routed to theappropriate treatment electrodes based on the appropriate stage of thesurgical operation being performed. Also, the tissue compression forcecan be adjusted to a suitable level based on the power, time, orproportion of the drive signal or signals that are delivered to thetissue.

In some aspects, the automatic adjustment of jaw clamp pressure may bebased on an algorithm implemented by a control circuit of the surgicalinstrument 112. As described above, the control circuit is configured toset and change various control parameters of the surgical instrument112, including clamp pressure, power delivered to treat tissue, andamplitude and frequency of waveform/drive signal output by thegenerator. Each energy modality may generally correspond to acompression force. For example, the RF (whether bipolar or monopolar)energy modality generally requires a higher extent of tissue pressurecompared to the ultrasonic energy modality. The high tissue compressionforces used for low operating temperature RF energy may be advantageousfor treating soft and connective tissue. Bipolar RF energy may requireeven higher tissue compression forces as opposed to those used inmonopolar RF energy applications. In one aspect, the compression forceadjustment algorithm may be adjusted based on a proportion of two ormore different energy modalities. That is, two energy modalities couldbe applied during a surgical procedure and the proportion of time spenton each modality could be used in an algorithm to calculate suitabletissue compression forces to be applied during the surgical procedure.Energy according to the blended multiple energy modalities could bedelivered simultaneously or substantially simultaneously. Thesituationally aware compression force adjustment algorithm may also bedynamically modified or updated via the surgical instrument 112receiving an update from a corresponding surgical hub or the cloud.

FIG. 45 is a logic flow diagram 135000 depicting a control program or alogic configuration to adjust compression force applied to tissue, basedon one or more selected energy modalities, according to a least oneaspect of the present disclosure. The compression force is adjustablefor a surgical procedure performed with a surgical instrument 112. Acontrol circuit or processor of the surgical instrument 112 (FIGS.10-17) or hub 106 (e.g., processor 244 FIG. 8) determines 135002 a typeof tissue (which includes any tissue described herein, but is referredto as tissue 8410 for the sake of clarity) being treated by the surgicalinstrument 112. Tissue types include, for example, connective tissue(e.g., blood vessels), muscular tissue, and bronchus tissue. Tissuetypes could be detected or determined in a number of ways, such as byusing spectral analysis of tissue bites. As discussed above, spectralanalysis of different jaw bites and device states produces differentcomplex impedance characteristic patterns (fingerprint) across a rangeof frequencies for different conditions and states. Spectroscopy may beapplied to surgical instrument 112 by exciting the tip of the ultrasonicblade of the surgical instrument 112 with a sweep of frequencies, forexample. The complex impedance characteristic patterns across a range offrequencies could be used in a model or classifier to infer tissuetypes.

Aside from inferring tissue type, tissue characteristics such as tissuethickness and stiffness may be determined, for example. Thedetermination or inference of tissue type and tissue characteristics maybe performed by the control circuit, including control circuit 500, 710,760, 3200, 3300, 3402, 3502, 3686, 3900. For the sake of clarity,control circuit 3900 is referenced in this portion of the presentdisclosure. Control circuit 3900 may comprise the processors describedabove, as appropriate, including processors 822, 1740, 1900, 3214, 3302.In one aspect, the control circuit 3900 may cause the generator to applya non-therapeutic signal to the end effector over a range offrequencies. Subsequently, the control circuit 3900 can determine thetissue impedance based on the impedance characteristic pattern derivedfrom spectral analysis of the non-therapeutic signal, as discussedabove. For the sake of clarity, generator 1100 is referred to in thisportion although the generator may be any generator described here,including generator 800, 900, 1100, 4002. Also for the sake of clarity,end effector 8400 is referenced in this portion although the endeffector may be any end effector described above, including end effector702, 752, 792, 1122. In some aspects, the generator 1100 comprises thecontrol circuit 3900; that is, the control circuit 3900 can be acomponent of the generator 1100.

Based on the tissue type and characteristic determination thesituationally aware surgical instrument 112 might infer 135002 a type ofsurgical procedure or tissue treatment. Alternatively, a suitablesurgical procedure could be manually determined or input by theclinician using the surgical instrument 112. Based on the surgicalprocedure to be performed, a first energy modality is selected 135004 bythe control circuit 3900 so that energy may be delivered by thegenerator 1100 to tissue 8410 grasped by the end effector 8400.Delivering energy may comprise outputting drive signals according to theselected energy modality (e.g., ultrasonic drive signals) or electricalsignal waveforms (e.g., current waveform determined based on LUT 2260and used to drive the ultrasonic transducer 1120 or digital waveform4300). As described above, the drive signal may have the waveform shapeof the waveform generated by the generator 1100 or control circuit 3900.Based on the surgical procedure, a second energy modality is selected135006 by the control circuit 3900. More than two energy modalitiescould also be selected by the control circuit 3900. The control circuit3900 or generator 1100 may then generate signal waveforms according toor based on the selected energy modalities or a tissue treatmentalgorithm, which could be received from the corresponding hub 106, 206or cloud 104, 204. As discussed above, energy modalities includeultrasonic, bipolar or monopolar RF, irreversible and/or reversibleelectroporation, and/or microwave energy, among others. Energymodalities can be selected depending on the type of treatment of tissuebeing performed. For example, the first and second energy modalitiescould be the ultrasonic energy modality and bipolar RF energy modality,respectively.

A tissue treatment algorithm is determined 135008. As discussed above,the surgical instrument 112 may receive 112 may receive the tissuetreatment algorithm from an external source. Additionally oralternatively, the control circuit 3900 may determine the tissuetreatment algorithm or an adjustment to the received algorithm based onthe determined tissue type and selected energy modalities from steps135002, 135004, 135006. In particular, the tissue treatment algorithmmay define parameters of the surgical treatment such as the power andtiming of the drive signal and the proportion of the energy modalities.Such parameters also may be dynamically adjusted by control circuit 3900or generator 1100 during performance of the surgical procedure. Ingeneral, the tissue treatment algorithm could be inferred by thesurgical instrument 112, received by the surgical instrument 112 throughthe corresponding surgical hub or cloud, or manually set by theclinician. The generator 1100 may infer what energy modality to applybased on feedback conditions or other sensed data received by thegenerator. For example, undeformed tissue thickness could be detectedvia a contact sensor 738 and could be used as one example characteristicin the inference of tissue type. As discussed above, different energymodalities may be advantageous for different tissue types andtreatments. For example, ultrasonic energy may be well suited fortreating smaller tissue 8410 (e.g., a small blood vessel). Inparticular, treatment with an ultrasonic blade may be appropriate forultrasonic coagulation of a small vessel.

In contrast, RF energy may be more suitable for cauterization of largertissue. To this end, as discussed above, the generator 1100 may deliverenergy with higher voltage and lower current to drive an ultrasonictransducer, with lower voltage and higher current to drive RF electrodesfor sealing tissue 8410, or with a coagulation waveform for spotcoagulation using either monopolar or bipolar RF electrosurgicalelectrodes. In one aspect, the treatment tissue algorithm may specifythe times during a surgical procedure that a particular energy modalityis applied (e.g., RF versus ultrasonic). For example, the algorithm maydefine that a mixture of RF and ultrasonic energy are delivered duringthe sealing stage of the surgical procedure and only ultrasonic energyis delivered during the cutting stage. To this end, the generator 1100may deliver ultrasonic and electrosurgical RF energy simultaneously fromits output port to provide the desired output drive signal. The mixtureof RF and ultrasonic could be applied simultaneously or substantiallysimultaneously as a blended energy modality or the generator 1100 couldbe configured to switch between delivering energy according to the RFand ultrasonic energy modalities (e.g., by switching between RFgenerator circuit 3902 and the ultrasonic generator circuit 3920 energymodalities). The treatment tissue algorithm may also specify the powerat which the energy modalities are applied. For example, as discussedabove, the waveform generator 904 and processor 902 of the generator1100 are configured to generate signal waveforms of various amplitudes(the power parameter could be set by controlling the input of the poweramplifier 1620 to set a particular waveform amplitude). The treatmenttissue algorithm can also define how the amplitude, frequency and shapeof the waveforms output by the generator 1100 changes over the course ofthe surgical procedure being performed.

The generator 1100 delivers 135010 energy to the tissue 8410 accordingto the desired tissue treatment algorithm. It may be possible to changethe tissue treatment algorithm during performance of the surgicalprocedure, such as via manual input by the clinician or data transmittedby the corresponding hub 106, 206 or cloud 104, 204. Also, as discussedabove, tissue compression force and energy delivered to the tissue 8410can vary inversely. As such, in some situations when the amplitude ofthe waveform output by the generator 1100 increases, the compressionforce may be decreased. Similarly, when the amplitude decreases, thecompression force may be increased. In other situations, the compressionforce may stay the same even as the amplitude changes. Similarly, thecompression force may change even as the amplitude stays constant. Thesituationally aware surgical instrument 112 may determine the proportionof the first energy modality versus the second energy modality. Forexample, a clock generator (e.g., clock 3330) may produce a clock signalused to track the duration that RF waveforms are applied and theduration that ultrasonic waveforms are applied during a surgicaloperation. Accordingly, the control circuit 3900 calculates 135012 theproportion of the first energy modality to the second energy modality.The control circuit 3900 may calculate 135012 the proportion based on atime or duration of the respective waveforms/drive signals of theselected energy modalities are applied as well as a frequency oramplitude of the respective waveforms. The proportion of additionalenergy modalities (e.g., a third energy modality) may also be calculated135012 if such additional modalities are used.

In one aspect, the compression force corresponding to one energymodality is relatively higher. That is, a range of compression force atwhich RF energy is applied may be greater than the range of compressionforce at which ultrasonic energy is applied. The proportion of energymodalities may be used to determine an appropriate level to set thepressure exerted by the end effector 8400. In other words, theproportion may be used to determine an appropriate tissue gap size ofthe end effector 8400 jaws. For some surgical instruments 112, the jawsof the end effector 8400 may be considered the clamp arm and theultrasonic blade or waveguide. For the sake of clarity, clamp arm 716 isreferenced in this portion although the clamp arm may be any clamp armdescribed in the present disclosure, including clamp arm 716, 766, 1140,1142 a, 1142 b. Similarly, ultrasonic blade 718 is referenced in thisportion of the present disclosure although the ultrasonic blade may beany ultrasonic blade described here, including ultrasonic blade 718,768, 1128. When trigger such as trigger 4010 is actuated, the endeffector 8400 closes such as tissue 8410 is clamped between the clamparm 716 and ultrasonic blade 718. In one aspect, the first energymodality such as the ultrasonic energy modality corresponds to a higherlevel of compression force while the second energy modality such as theRF energy modality corresponds to a lower level of compression force.The processor or control circuit may adjust 135014 tissue compressionbased on the calculated 135012 proportion. For example, a surgicalprocedure in which more ultrasonic energy and less RF energy aredelivered may result in an overall algorithmic adjustment to greatertissue compression force. Similarly, a procedure in which lessultrasonic energy and more RF energy are delivered may result in anoverall algorithmic adjustment to lesser tissue compression force.

When ultrasonic energy and RF energy are delivered simultaneously orsubstantially simultaneously, the overall proportion of ultrasonic to RFenergy may be used to determine the appropriate compression force. Moregenerally, the proportion of selected energy modalities is useable bythe control circuit 3900 to determine the adjustment. In one example, alower proportion of ultrasonic to RF energy would correspond to a highercompression force compared to the compression force corresponding to ahigher proportion. Also, the timing and power parameter of the deliveredenergy modalities during the surgical procedure may be considered forthe adjustment 135014 by the control circuit 3900. For example, ifrelatively high power RF energy is delivered at the sealing stage, thenthis may result in a smaller increase or adjustment to compression forcethan compared to a situation in which relatively high power RF energy isdelivered at the cutting stage. Moreover, the tissue compression forceadjustment may be made for only a discrete portion of the surgicalprocedure being performed. The timing and duration of the compressionforce adjustment can be determined based on the calculated proportion,selected tissue treatment algorithm, and tissue type andcharacteristics, among other possible considerations. As discussed infurther detail below, both mechanical and electrical methods areprovided to adjust the tissue gap size and consequently the appliedpressure/compression force. That is, the control circuit 3900 may usethe disclosed mechanical or electrical methods to adjust the size of thegap defined between the clamp arm 716 and ultrasonic blade 718. Audiblefeedback could be provided in the trigger 4010, for example, to indicatethat the applied compression force was adjusted. Also, the amount of theadjustment could be displayed in a display of the surgical instrument112, based on the control circuit 3900 assessing the compression forcesapplied to the clamp arm 716. The logic flow diagram 135000 of FIG. 45could also be performed by a control circuit or processor the generator1100.

FIG. 46 illustrates a mechanical method of adjusting compression forceapplied by an end effector 135100 for different treatment types,according to one aspect of the present disclosure. End effector 135100of the surgical instrument 112 is the same as or similar to other endeffectors described above, such as end effector 702, 752, 792, 1122,8400. Accordingly, end effector 135100 may comprise two jaw members. Invarious aspects, the jaw members are a clamp arm 135102 and a waveguideor blade 135104. The clamp arm 135102, which is the same or similar toclamp arm 716, 766, 1140, 1142 a, 1142 b, and the blade 135104, which isthe same or similar to ultrasonic blade 718, 768, 1128, can beconfigured to rotate. For example, as shown in FIG. 46-47B, theultrasonic blade 135104 is rotatable three hundred and sixty degrees.Additionally or alternatively, the clamp arm 135102 is also rotatablethree hundred and sixty degrees. In this way, as illustrated in FIG. 46,the ultrasonic blade 135104 can be transitioned between a horizontal orlandscape orientation to a vertical or portrait orientation, includingintermediate positions, which may be in between the horizontal andvertical orientations or may exceed ninety degrees.

Stated differently, the ultrasonic blade 135104 has a zero degreeorientation corresponding to a horizontal orientation and a ninetydegree orientation corresponding to a vertical orientation. With theclamp arm 135102 held in a constant or substantially constant position(shown in FIG. 46), the ultrasonic blade 135104 is rotatable to define aspectrum of clamp pressure. An opposite configuration is also possiblesuch that the ultrasonic blade 135104 is the constant jaw member ratherthan the clamp arm 135102. In one aspect, as the ultrasonic blade 135104rotates from zero degrees to ninety degrees, the tissue compressionforce increases from a low force to a high force. The tissue gapresulting from the zero degree orientation may be called low clamp135106 while the tissue gap resulting from ninety degrees orientationmay be called high clamp 135108. Various orientations of ultrasonicblade 135104 correspond to the same level of compression pressure. Forexample, zero degrees and one hundred and eighty degrees both correspondto low clamp 135106. FIG. 46 depicts the low clamp 135106, high clamp135108, and a third orientation 135110. The third orientation 135110depicted in FIG. 46 is slightly greater than ninety degrees, such as aone hundred and twenty degree orientation. Consequently, this thirdorientation 135110 defines a tissue gap size that is slightly smallerthan the tissue gap corresponding to high clamp 135108.

In the horizontal orientation (low clamp) 135106, the ultrasonic blade135104 may be configured for tissue sealing (e.g., coagulation orcauterization). In the vertical orientation (high clamp) 135108, theultrasonic blade 135104 may be configured for tissue cutting ordissection. As discussed above, the RF energy modality may generallycorrespond to a greater tissue compression force. Accordingly, in oneaspect, the horizontal orientation 135106 corresponds to the ultrasonicenergy modality while the vertical orientation 135108 corresponds to theRF energy modality. Other intermediate positions, including thirdorientation 135110, may be used as appropriate during the surgicaloperation. For example, an RF waveform of relatively high power and anintermediate orientation such as 60 degrees may be used when surgicaltreatment initially commences. Furthermore, the ultrasonic blade 135104orientation may change throughout a performed surgical procedureaccording to the selected 135008 tissue treatment algorithm, forexample. In another aspect, the ultrasonic blade 135104 may be an ovalshape and offset relative to the clamp arm 135102.

Other mechanical methods of adjusting compression force are disclosed.For example, the clamp arm 135102 or ultrasonic blade 135104 may bemoveable such that the end effector 135100 is configurable between aclosed configuration, an open configuration, and intermediate positionsin between to define various clamp pressures. In one aspect, amechanical switch such as a momentary-action manual switch,mechanical-bail switch, capacitive touch switch, membrane switch, orother suitable mechanical switch of the surgical instrument 112 cantransition between two positions. The control circuit 3900 may controloperation of the mechanical switch. The first and second positions maycorrespond to a first and second compression force level, which in turnmay correspond to a first and second energy modality, respectively.Thus, for example, in the first position, the mechanical switch couldcause an adjustment to the stroke or longitudinal movement of anactuator rod. The actuator rod may refer to a suitable end effector135100 actuation mechanism, such as the linkage components oftransmissions 706 a-706 e to couple motors 704 a-704 e.

In particular, the actuator rod may comprise linkage elements similar toor the same as transmissions 706 a-706 e used to transmit mechanicalenergy from the motors 704 a-704 b to actuate or close closure member714 and clamp arm 716, respectfully. The actuation stroke of theactuator rod could be adjusted by the control circuit 3900 to achievethe different compression forces of the end effector 1351000. With theadjustment caused by the first position of the mechanical switch,actuation of the actuator rod may result in a clamp arm 135102orientation corresponding to a relatively large tissue gap. Conversely,in the second position, the mechanical switch could cause a differentadjustment such that actuation of the actuator rod may result in a clamparm 135102 orientation corresponding to a relatively small tissue gap.The first position could correspond to the delivery of energy accordingto the ultrasonic modality while the second position could correspond tothe delivery of energy according to the RF modality. In one aspect, byshifting between the first and second position, the mechanical switchshifts the pivotal linkage or coupling between the actuator rod and theclamp arm 135102. In this way, the control circuit 3900 can control themechanical switch to implement adjustments to actuator stroke which inturn results in various clamp arm 135102 configurations (between andincluding open and closed configurations) that correspond to differenttissue compression forces. Other suitable mechanical means of adjustingthe actuator stroke or clamp arm configuration are also possible.

FIGS. 47A-47B illustrate a mechanical method of adjusting compressionforce applied by an end effector 135200 for different treatment types,by rotating an ultrasonic blade 135204, according to aspects of thepresent disclosure. End effector 135200 and ultrasonic blade 135204 arethe same as or similar to end effector 135100 and ultrasonic blade135104, respectively. The ultrasonic blade 135204 is rotatable between avertical and a horizontal configuration, as shown in FIGS. 47A-47B. Inone aspect, the end effector 135200 comprises a jaw member 135202 (e.g.,clamp arm 135102, 716), flexible circuit 135206 and the ultrasonic blade135204. Additionally or alternatively, the jaw member 135202 may berotatable as well.

FIG. 47A depicts tissue 135208 located between the jaw member 135202 andthe ultrasonic blade 135204. In the horizontal orientation shown, theultrasonic blade 135204 is at or substantially at a zero degreeorientation. Accordingly, relatively low compression force is applied tothe tissue 135208. In one aspect, the ultrasonic blade 135204 isconfigured for tissue sealing (e.g., cauterization) in the horizontalorientation. The ultrasonic blade 135204 also comprises side lobesections 135210 a, 135210 b to enhance tissue dissection and uniformsections 135212 a, 135212 b to enhance tissue sealing. As discussedabove, the control circuit 3900 may control rotation of the jaw member135202 or ultrasonic blade 135204.

FIG. 47B depicts the vertical orientation in which the ultrasonic blade135204 is at or substantially at a ninety degree orientation. In anotheraspect, the ultrasonic blade 135204 is configured for tissue dissectionin the vertical orientation. The flexible circuit 135206 may includeelectrodes such that when a RF energy modality is selected, theelectrodes are configured to deliver high-frequency RF current to thetissue 135208. The electrodes may be the same or similar to electrodesdescribed in the present disclosure, such as electrodes 796, 3074 a,3074 b, 3906 a, 3906 b. Lower-frequency RF current is also possible.When the RF energy modality is selected, the ultrasonic blade 135204 mayact as the electrical ground for the RF waveform output from thegenerator 1100. That is, the RF electrodes (e.g., RF electrodes 796)could be coupled to the positive pole while the ultrasonic blade 135204is coupled to the negative or return pole. In some configurations, thepolarity may be reversed such that the RF electrodes 796 are coupled tothe negative pole and the ultrasonic blade 135204 is coupled to thepositive pole. In one aspect, when both the RF and ultrasonic energymodalities are selected, the RF current conducted by the electrodes 796is used to seal the tissue 135208 and the ultrasonic blade 135204 isused to dissect tissue based on ultrasonic vibrations propagatingthrough ultrasonic blade 135204. As discussed above with respect to FIG.40, other intermediate orientations of the rotatable ultrasonic blade135204 may also be possible, so that additional levels of differentcompression forces may be adjusted and applied to tissue 135208 asappropriate.

Electrical methods of adjusting compression force between treatmenttypes are also disclosed. For example, a suitable EAP may be used as anelectrostatic actuator for changing tissue gap size. EAPs are voltageactivated elastomers which can be electronic EAPs such aselectrostrictive elastomers and dielectric electroactive polymers(DEAPs) or ionic EAPs such as ionic polymer metal composites (IPMCs).EAPs have an electromechanical thickness or other strain that is inducedby electrostatic forces. Stated differently, when a voltage is appliedto an EAP, the EAP bends, contracts, or expands. An EAP actuator may beused in the surgical instrument 112 to change the tissue gap size forchanging the applied compression forces based on application of avoltage potential to the EAP. The EAP actuator may be controlled by thecontrol circuit 3900. For example, the EAP may be configured to expand,which causes the application of more pressure on the blade 135204 orelectrodes 796 positioned in the end effector 135200. To this end, theEAP may be positioned in the end effector 135200 between the powersource (e.g., generator) and RF electrodes 796. For example, the EAPcould be part of the flexible circuit 135206. In this way, as an RFwaveform is output from the generator 1100, voltage is applied to theEAP, which causes the EAP to expand and apply a force on the RFelectrodes such that the tissue gap size decreases. In general, the EAPmay expand as the generator 1100 delivers energy according to theselected energy modalities.

Additionally or alternatively, when the EAP expands, this causes a forceto be applied to the blade 135200 such that the tissue gap sizedecreases. Conversely, the EAP may be positioned and configured suchthat electrostatic actuation causes the EAP to contract, which reducesthe compression force applied to the tissue. The change in the size ofthe EAP may be proportional to the voltage used for EAP actuation andthe adjustment to compression force that results. In one aspect, the EAPmay also be positioned in the shaft of the surgical instrument 112, forexample, such that electrostatic actuation causes the EAP to exertfurther force on the clamp arm 135102 or the end effector 135200.Similarly, the EAP could be configured to remove or reduce force appliedby the clamp arm 135102. In this way, the EAP actuator may be employedto change the end effector configuration, which spans between the openand closed configurations. In general, the EAP could be provided suchthat the control circuit 3900 can increase compression force as agreater proportion of energy is delivered according to the RF energymodality. Similarly, the EAP could be used to adjust pressure as anotherenergy modality such as the ultrasonic energy modality is selected. TheEAP could be part of the flexible circuit 135206, for example.

In general, the end effector 135200 of the surgical instrument 112 maycomprise an ultrasonic blade 135200 and a clamp arm 135102, which mayfunction as the first and second jaws of the end effector 135200. Theend effector 135200 is configured to clamp tissue therebetween the jaws,fire fasteners through the clamped tissue 135208, sever the clampedtissue 135208, and grasp tissue 135208 for application of energyaccording to the selected energy modality. Moreover, the force appliedto the tissue 135208 by the end effector 135200 may be measured by thestrain gauge sensor 474, such as by measuring the amplitude or magnitudeof the strain exerted on a jaw member of the end effector 135200 duringa clamping operation. As discussed above, energy may be deliveredaccording to multiple energy modalities such as RF and ultrasonicenergy, in conjunction to achieve surgical sealing, cutting, andcoagulation functions. Although energy from the generator 1100 could bedelivered simultaneously such as through simultaneously delivering oroutputting waveforms from the generator 1100 to the RF electrodes 796and the ultrasonic transducer 1120 in conjunction, such energy deliverycan also switch between different energy modalities.

FIG. 48 shows a diagram 135300 illustrating switching between activeelectrodes of an end effector 135200 according to one aspect of thepresent disclosure. Again, the electrodes may be the same or similar toelectrodes 796, 3074 a, 3074 b, 3906 a, 3906 b. As discussed above, thesituationally aware surgical instrument 112 may infer or determine anappropriate tissue treatment algorithm for the surgical procedure beingperformed. The tissue compression force adjustment is made based on thisalgorithm and the proportion of selected energy modalities. In addition,the tissue compression force adjustment may be made based on switchingfrom a passive electrode to an active electrode for treatment, as shownin FIG. 48. For example, the situationally aware surgical instrument 112may detect a selected function of the surgical instrument 112 such assealing or cutting. Based on the selected function, a switch, filter, orother suitable wiring such as a relay or transistor may be provided tocontrol routing the waveform (e.g., waveform 4300) output by thegenerator 1100 to an appropriate electrode. FIG. 49 depicts the endeffector 135200 with a first set of two treatment electrodes “A” 135302and a second set of two treatment electrodes “B” 135304, both of whichmay alternate between active or passive states. The two sets oftreatment electrodes 135302, 135304 are provided on both jaws of the endeffector 135200. Based on which treatment electrode is active orpassive, the applied compression force may be adjusted.

In one aspect, the “A” electrodes 135302 are configured for the sealingstage and the “B” electrodes 135304 are configured for the cuttingstage. These configurations could be used by the surgical instrument 112to determine if and what compression force adjustment is required whenan energy modality is selected. For example, when the “A” electrodes135302 become passive while the “B” electrodes 135304 become active, thesurgical instrument 112 may adjust the compression force. This could bean adjustment to decrease the compression force, such as because theadditional power delivered during the cutting stage might not require asmuch corresponding compression force. The extent of the adjustment candepend on the proportion of one energy modality (e.g., RF) to another(e.g., ultrasonic) as calculated throughout the duration of theperformed surgical operation. In one aspect, the switch is configured toroute the output energy by the generator 1100 to the sealing electrodes“A” 135302 while the surgical instrument 112 is used for coagulation.Multiple impedance thresholds 135306, 135308 may be provided, which areindicated on the impedance graph (Z) 135312 in FIG. 48 as dotted lines.FIG. 48 shows that when threshold 135306 is crossed at point 135310, thecrossing may indicate when optimal tissue coagulation is complete. Thatis, when the measured tissue impedance reaches point 135310, it may bedetermined that a sufficiently secure tissue seal has formed.

As discussed above, impedance may be measured by dividing the output ofthe voltage sensing circuit and the current sensing circuit or by usingspectral analysis, for example. When coagulation is complete, the switchmay transition to a second position to route a different waveform fromthe generator 1100, in which the amplitude of the different waveform israised relative to the waveform used for coagulation. The differentwaveform may be applied for surgical cutting rather than forcoagulation. Accordingly, the switch may route this different waveformto the “B” electrodes 135304. As can be seen in the power graph 135314of FIG. 48, the amplitude of the waveform is greater than the amplitudeof the coagulation waveform. Although the power levels shown in powergraph 135314 are constant, dynamic power levels may be used as well. Asdiscussed above, the increase in power from “A” electrodes 135302 to “B”electrodes 135304 may trigger an adjustment to tissue compression, whichmay be determined based on the proportion of one selected energymodality to another. In another aspect, the surgical cutting achievedvia the “B” electrodes 135304 is a knifeless cutting. Although theenergy modality selected for the tissue treatment illustrated in FIG. 49may be RF, other energy modalities may be used for such treatment andover the course of a performed surgical operation.

Situational Awareness

Referring now to FIG. 49, a timeline 5200 depicting situationalawareness of a hub, such as the surgical hub 106 or 206, for example, isdepicted. The timeline 5200 is an illustrative surgical procedure andthe contextual information that the surgical hub 106, 206 can derivefrom the data received from the data sources at each step in thesurgical procedure. The timeline 5200 depicts the typical steps thatwould be taken by the nurses, surgeons, and other medical personnelduring the course of a lung segmentectomy procedure, beginning withsetting up the operating theater and ending with transferring thepatient to a post-operative recovery room.

The situationally aware surgical hub 106, 206 receives data from thedata sources throughout the course of the surgical procedure, includingdata generated each time medical personnel utilize a modular device thatis paired with the surgical hub 106, 206. The surgical hub 106, 206 canreceive this data from the paired modular devices and other data sourcesand continually derive inferences (i.e., contextual information) aboutthe ongoing procedure as new data is received, such as which step of theprocedure is being performed at any given time. The situationalawareness system of the surgical hub 106, 206 is able to, for example,record data pertaining to the procedure for generating reports, verifythe steps being taken by the medical personnel, provide data or prompts(e.g., via a display screen) that may be pertinent for the particularprocedural step, adjust modular devices based on the context (e.g.,activate monitors, adjust the field of view (FOV) of the medical imagingdevice, or change the energy level of an ultrasonic surgical instrumentor RF electrosurgical instrument), and take any other such actiondescribed above.

As the first step S202 in this illustrative procedure, the hospitalstaff members retrieve the patient's EMR from the hospital's EMRdatabase. Based on select patient data in the EMR, the surgical hub 106,206 determines that the procedure to be performed is a thoracicprocedure.

Second step S204, the staff members scan the incoming medical suppliesfor the procedure. The surgical hub 106, 206 cross-references thescanned supplies with a list of supplies that are utilized in varioustypes of procedures and confirms that the mix of supplies corresponds toa thoracic procedure. Further, the surgical hub 106, 206 is also able todetermine that the procedure is not a wedge procedure (because theincoming supplies either lack certain supplies that are necessary for athoracic wedge procedure or do not otherwise correspond to a thoracicwedge procedure).

Third step S206, the medical personnel scan the patient band via ascanner that is communicably connected to the surgical hub 106, 206. Thesurgical hub 106, 206 can then confirm the patient's identity based onthe scanned data.

Fourth step S208, the medical staff turns on the auxiliary equipment.The auxiliary equipment being utilized can vary according to the type ofsurgical procedure and the techniques to be used by the surgeon, but inthis illustrative case they include a smoke evacuator, insufflator, andmedical imaging device. When activated, the auxiliary equipment that aremodular devices can automatically pair with the surgical hub 106, 206that is located within a particular vicinity of the modular devices aspart of their initialization process. The surgical hub 106, 206 can thenderive contextual information about the surgical procedure by detectingthe types of modular devices that pair with it during this pre-operativeor initialization phase. In this particular example, the surgical hub106, 206 determines that the surgical procedure is a VATS procedurebased on this particular combination of paired modular devices. Based onthe combination of the data from the patient's EMR, the list of medicalsupplies to be used in the procedure, and the type of modular devicesthat connect to the hub, the surgical hub 106, 206 can generally inferthe specific procedure that the surgical team will be performing. Oncethe surgical hub 106, 206 knows what specific procedure is beingperformed, the surgical hub 106, 206 can then retrieve the steps of thatprocedure from a memory or from the cloud and then cross-reference thedata it subsequently receives from the connected data sources (e.g.,modular devices and patient monitoring devices) to infer what step ofthe surgical procedure the surgical team is performing.

Fifth step S210, the staff members attach the EKG electrodes and otherpatient monitoring devices to the patient. The EKG electrodes and otherpatient monitoring devices are able to pair with the surgical hub 106,206. As the surgical hub 106, 206 begins receiving data from the patientmonitoring devices, the surgical hub 106, 206 thus confirms that thepatient is in the operating theater.

Sixth step S212, the medical personnel induce anesthesia in the patient.The surgical hub 106, 206 can infer that the patient is under anesthesiabased on data from the modular devices and/or patient monitoringdevices, including EKG data, blood pressure data, ventilator data, orcombinations thereof, for example. Upon completion of the sixth stepS212, the pre-operative portion of the lung segmentectomy procedure iscompleted and the operative portion begins.

Seventh step S214, the patient's lung that is being operated on iscollapsed (while ventilation is switched to the contralateral lung). Thesurgical hub 106, 206 can infer from the ventilator data that thepatient's lung has been collapsed, for example. The surgical hub 106,206 can infer that the operative portion of the procedure has commencedas it can compare the detection of the patient's lung collapsing to theexpected steps of the procedure (which can be accessed or retrievedpreviously) and thereby determine that collapsing the lung is the firstoperative step in this particular procedure.

Eighth step S216, the medical imaging device (e.g., a scope) is insertedand video from the medical imaging device is initiated. The surgical hub106, 206 receives the medical imaging device data (i.e., video or imagedata) through its connection to the medical imaging device. Upon receiptof the medical imaging device data, the surgical hub 106, 206 candetermine that the laparoscopic portion of the surgical procedure hascommenced. Further, the surgical hub 106, 206 can determine that theparticular procedure being performed is a segmentectomy, as opposed to alobectomy (note that a wedge procedure has already been discounted bythe surgical hub 106, 206 based on data received at the second step S204of the procedure). The data from the medical imaging device 124 (FIG. 2)can be utilized to determine contextual information regarding the typeof procedure being performed in a number of different ways, including bydetermining the angle at which the medical imaging device is orientedwith respect to the visualization of the patient's anatomy, monitoringthe number or medical imaging devices being utilized (i.e., that areactivated and paired with the surgical hub 106, 206), and monitoring thetypes of visualization devices utilized. For example, one technique forperforming a VATS lobectomy places the camera in the lower anteriorcorner of the patient's chest cavity above the diaphragm, whereas onetechnique for performing a VATS segmentectomy places the camera in ananterior intercostal position relative to the segmental fissure. Usingpattern recognition or machine learning techniques, for example, thesituational awareness system can be trained to recognize the positioningof the medical imaging device according to the visualization of thepatient's anatomy. As another example, one technique for performing aVATS lobectomy utilizes a single medical imaging device, whereas anothertechnique for performing a VATS segmentectomy utilizes multiple cameras.As yet another example, one technique for performing a VATSsegmentectomy utilizes an infrared light source (which can becommunicably coupled to the surgical hub as part of the visualizationsystem) to visualize the segmental fissure, which is not utilized in aVATS lobectomy. By tracking any or all of this data from the medicalimaging device, the surgical hub 106, 206 can thereby determine thespecific type of surgical procedure being performed and/or the techniquebeing used for a particular type of surgical procedure.

Ninth step S218, the surgical team begins the dissection step of theprocedure. The surgical hub 106, 206 can infer that the surgeon is inthe process of dissecting to mobilize the patient's lung because itreceives data from the RF or ultrasonic generator indicating that anenergy instrument is being fired. The surgical hub 106, 206 cancross-reference the received data with the retrieved steps of thesurgical procedure to determine that an energy instrument being fired atthis point in the process (i.e., after the completion of the previouslydiscussed steps of the procedure) corresponds to the dissection step. Incertain instances, the energy instrument can be an energy tool mountedto a robotic arm of a robotic surgical system.

Tenth step S220, the surgical team proceeds to the ligation step of theprocedure. The surgical hub 106, 206 can infer that the surgeon isligating arteries and veins because it receives data from the surgicalstapling and cutting instrument indicating that the instrument is beingfired. Similarly to the prior step, the surgical hub 106, 206 can derivethis inference by cross-referencing the receipt of data from thesurgical stapling and cutting instrument with the retrieved steps in theprocess. In certain instances, the surgical instrument can be a surgicaltool mounted to a robotic arm of a robotic surgical system.

Eleventh step S222, the segmentectomy portion of the procedure isperformed. The surgical hub 106, 206 can infer that the surgeon istransecting the parenchyma based on data from the surgical stapling andcutting instrument, including data from its cartridge. The cartridgedata can correspond to the size or type of staple being fired by theinstrument, for example. As different types of staples are utilized fordifferent types of tissues, the cartridge data can thus indicate thetype of tissue being stapled and/or transected. In this case, the typeof staple being fired is utilized for parenchyma (or other similartissue types), which allows the surgical hub 106, 206 to infer that thesegmentectomy portion of the procedure is being performed.

Twelfth step S224, the node dissection step is then performed. Thesurgical hub 106, 206 can infer that the surgical team is dissecting thenode and performing a leak test based on data received from thegenerator indicating that an RF or ultrasonic instrument is being fired.For this particular procedure, an RF or ultrasonic instrument beingutilized after parenchyma was transected corresponds to the nodedissection step, which allows the surgical hub 106, 206 to make thisinference. It should be noted that surgeons regularly switch back andforth between surgical stapling/cutting instruments and surgical energy(i.e., RF or ultrasonic) instruments depending upon the particular stepin the procedure because different instruments are better adapted forparticular tasks. Therefore, the particular sequence in which thestapling/cutting instruments and surgical energy instruments are usedcan indicate what step of the procedure the surgeon is performing.Moreover, in certain instances, robotic tools can be utilized for one ormore steps in a surgical procedure and/or handheld surgical instrumentscan be utilized for one or more steps in the surgical procedure. Thesurgeon(s) can alternate between robotic tools and handheld surgicalinstruments and/or can use the devices concurrently, for example. Uponcompletion of the twelfth step S224, the incisions are closed up and thepost-operative portion of the procedure begins.

Thirteenth step S226, the patient's anesthesia is reversed. The surgicalhub 106, 206 can infer that the patient is emerging from the anesthesiabased on the ventilator data (i.e., the patient's breathing rate beginsincreasing), for example.

Lastly, the fourteenth step S228 is that the medical personnel removethe various patient monitoring devices from the patient. The surgicalhub 106, 206 can thus infer that the patient is being transferred to arecovery room when the hub loses EKG, BP, and other data from thepatient monitoring devices. As can be seen from the description of thisillustrative procedure, the surgical hub 106, 206 can determine or inferwhen each step of a given surgical procedure is taking place accordingto data received from the various data sources that are communicablycoupled to the surgical hub 106, 206.

Situational awareness is further described in U.S. Provisional PatentApplication Ser. No. 62/611,341, titled INTERACTIVE SURGICAL PLATFORM,filed Dec. 28, 2017, which is herein incorporated by reference in itsentirety. In certain instances, operation of a robotic surgical system,including the various robotic surgical systems disclosed herein, forexample, can be controlled by the hub 106, 206 based on its situationalawareness and/or feedback from the components thereof and/or based oninformation from the cloud 102.

While several forms have been illustrated and described, it is not theintention of the applicant to restrict or limit the scope of theappended claims to such detail. Numerous modifications, variations,changes, substitutions, combinations, and equivalents to those forms maybe implemented and will occur to those skilled in the art withoutdeparting from the scope of the present disclosure. Moreover, thestructure of each element associated with the described forms can bealternatively described as a means for providing the function performedby the element. Also, where materials are disclosed for certaincomponents, other materials may be used. It is therefore to beunderstood that the foregoing description and the appended claims areintended to cover all such modifications, combinations, and variationsas falling within the scope of the disclosed forms. The appended claimsare intended to cover all such modifications, variations, changes,substitutions, modifications, and equivalents.

The foregoing detailed description has set forth various forms of thedevices and/or processes via the use of block diagrams, flowcharts,and/or examples. Insofar as such block diagrams, flowcharts, and/orexamples contain one or more functions and/or operations, it will beunderstood by those within the art that each function and/or operationwithin such block diagrams, flowcharts, and/or examples can beimplemented, individually and/or collectively, by a wide range ofhardware, software, firmware, or virtually any combination thereof.Those skilled in the art will recognize that some aspects of the formsdisclosed herein, in whole or in part, can be equivalently implementedin integrated circuits, as one or more computer programs running on oneor more computers (e.g., as one or more programs running on one or morecomputer systems), as one or more programs running on one or moreprocessors (e.g., as one or more programs running on one or moremicroprocessors), as firmware, or as virtually any combination thereof,and that designing the circuitry and/or writing the code for thesoftware and or firmware would be well within the skill of one of skillin the art in light of this disclosure. In addition, those skilled inthe art will appreciate that the mechanisms of the subject matterdescribed herein are capable of being distributed as one or more programproducts in a variety of forms, and that an illustrative form of thesubject matter described herein applies regardless of the particulartype of signal bearing medium used to actually carry out thedistribution.

Instructions used to program logic to perform various disclosed aspectscan be stored within a memory in the system, such as dynamic randomaccess memory (DRAM), cache, flash memory, or other storage.Furthermore, the instructions can be distributed via a network or by wayof other computer readable media. Thus a machine-readable medium mayinclude any mechanism for storing or transmitting information in a formreadable by a machine (e.g., a computer), but is not limited to, floppydiskettes, optical disks, compact disc, read-only memory (CD-ROMs), andmagneto-optical disks, read-only memory (ROMs), random access memory(RAM), erasable programmable read-only memory (EPROM), electricallyerasable programmable read-only memory (EEPROM), magnetic or opticalcards, flash memory, or a tangible, machine-readable storage used in thetransmission of information over the Internet via electrical, optical,acoustical or other forms of propagated signals (e.g., carrier waves,infrared signals, digital signals, etc.). Accordingly, thenon-transitory computer-readable medium includes any type of tangiblemachine-readable medium suitable for storing or transmitting electronicinstructions or information in a form readable by a machine (e.g., acomputer).

As used in any aspect herein, the term “control circuit” may refer to,for example, hardwired circuitry, programmable circuitry (e.g., acomputer processor comprising one or more individual instructionprocessing cores, processing unit, processor, microcontroller,microcontroller unit, controller, digital signal processor (DSP),programmable logic device (PLD), programmable logic array (PLA), orfield programmable gate array (FPGA)), state machine circuitry, firmwarethat stores instructions executed by programmable circuitry, and anycombination thereof. The control circuit may, collectively orindividually, be embodied as circuitry that forms part of a largersystem, for example, an integrated circuit (IC), an application-specificintegrated circuit (ASIC), a system on-chip (SoC), desktop computers,laptop computers, tablet computers, servers, smart phones, etc.Accordingly, as used herein “control circuit” includes, but is notlimited to, electrical circuitry having at least one discrete electricalcircuit, electrical circuitry having at least one integrated circuit,electrical circuitry having at least one application specific integratedcircuit, electrical circuitry forming a general purpose computing deviceconfigured by a computer program (e.g., a general purpose computerconfigured by a computer program which at least partially carries outprocesses and/or devices described herein, or a microprocessorconfigured by a computer program which at least partially carries outprocesses and/or devices described herein), electrical circuitry forminga memory device (e.g., forms of random access memory), and/or electricalcircuitry forming a communications device (e.g., a modem, communicationsswitch, or optical-electrical equipment). Those having skill in the artwill recognize that the subject matter described herein may beimplemented in an analog or digital fashion or some combination thereof.

As used in any aspect herein, the term “logic” may refer to an app,software, firmware and/or circuitry configured to perform any of theaforementioned operations. Software may be embodied as a softwarepackage, code, instructions, instruction sets and/or data recorded onnon-transitory computer readable storage medium. Firmware may beembodied as code, instructions or instruction sets and/or data that arehard-coded (e.g., nonvolatile) in memory devices.

As used in any aspect herein, the terms “component,” “system,” “module”and the like can refer to a computer-related entity, either hardware, acombination of hardware and software, software, or software inexecution.

As used in any aspect herein, an “algorithm” refers to a self-consistentsequence of steps leading to a desired result, where a “step” refers toa manipulation of physical quantities and/or logic states which may,though need not necessarily, take the form of electrical or magneticsignals capable of being stored, transferred, combined, compared, andotherwise manipulated. It is common usage to refer to these signals asbits, values, elements, symbols, characters, terms, numbers, or thelike. These and similar terms may be associated with the appropriatephysical quantities and are merely convenient labels applied to thesequantities and/or states.

A network may include a packet switched network. The communicationdevices may be capable of communicating with each other using a selectedpacket switched network communications protocol. One examplecommunications protocol may include an Ethernet communications protocolwhich may be capable permitting communication using a TransmissionControl Protocol/Internet Protocol (TCP/IP). The Ethernet protocol maycomply or be compatible with the Ethernet standard published by theInstitute of Electrical and Electronics Engineers (IEEE) titled “IEEE802.3 Standard”, published in December, 2008 and/or later versions ofthis standard. Alternatively or additionally, the communication devicesmay be capable of communicating with each other using an X.25communications protocol. The X.25 communications protocol may comply orbe compatible with a standard promulgated by the InternationalTelecommunication Union-Telecommunication Standardization Sector(ITU-T). Alternatively or additionally, the communication devices may becapable of communicating with each other using a frame relaycommunications protocol. The frame relay communications protocol maycomply or be compatible with a standard promulgated by ConsultativeCommittee for International Telegraph and Telephone (CCITT) and/or theAmerican National Standards Institute (ANSI). Alternatively oradditionally, the transceivers may be capable of communicating with eachother using an Asynchronous Transfer Mode (ATM) communications protocol.The ATM communications protocol may comply or be compatible with an ATMstandard published by the ATM Forum titled “ATM-MPLS NetworkInterworking 2.0” published August 2001, and/or later versions of thisstandard. Of course, different and/or after-developedconnection-oriented network communication protocols are equallycontemplated herein.

Unless specifically stated otherwise as apparent from the foregoingdisclosure, it is appreciated that, throughout the foregoing disclosure,discussions using terms such as “processing,” “computing,”“calculating,” “determining,” “displaying,” or the like, refer to theaction and processes of a computer system, or similar electroniccomputing device, that manipulates and transforms data represented asphysical (electronic) quantities within the computer system's registersand memories into other data similarly represented as physicalquantities within the computer system memories or registers or othersuch information storage, transmission or display devices.

One or more components may be referred to herein as “configured to,”“configurable to,” “operable/operative to,” “adapted/adaptable,” “ableto,” “conformable/conformed to,” etc. Those skilled in the art willrecognize that “configured to” can generally encompass active-statecomponents and/or inactive-state components and/or standby-statecomponents, unless context requires otherwise.

The terms “proximal” and “distal” are used herein with reference to aclinician manipulating the handle portion of the surgical instrument.The term “proximal” refers to the portion closest to the clinician andthe term “distal” refers to the portion located away from the clinician.It will be further appreciated that, for convenience and clarity,spatial terms such as “vertical”, “horizontal”, “up”, and “down” may beused herein with respect to the drawings. However, surgical instrumentsare used in many orientations and positions, and these terms are notintended to be limiting and/or absolute.

Those skilled in the art will recognize that, in general, terms usedherein, and especially in the appended claims (e.g., bodies of theappended claims) are generally intended as “open” terms (e.g., the term“including” should be interpreted as “including but not limited to,” theterm “having” should be interpreted as “having at least,” the term“includes” should be interpreted as “includes but is not limited to,”etc.). It will be further understood by those within the art that if aspecific number of an introduced claim recitation is intended, such anintent will be explicitly recited in the claim, and in the absence ofsuch recitation no such intent is present. For example, as an aid tounderstanding, the following appended claims may contain usage of theintroductory phrases “at least one” and “one or more” to introduce claimrecitations. However, the use of such phrases should not be construed toimply that the introduction of a claim recitation by the indefinitearticles “a” or “an” limits any particular claim containing suchintroduced claim recitation to claims containing only one suchrecitation, even when the same claim includes the introductory phrases“one or more” or “at least one” and indefinite articles such as “a” or“an” (e.g., “a” and/or “an” should typically be interpreted to mean “atleast one” or “one or more”); the same holds true for the use ofdefinite articles used to introduce claim recitations.

In addition, even if a specific number of an introduced claim recitationis explicitly recited, those skilled in the art will recognize that suchrecitation should typically be interpreted to mean at least the recitednumber (e.g., the bare recitation of “two recitations,” without othermodifiers, typically means at least two recitations, or two or morerecitations). Furthermore, in those instances where a conventionanalogous to “at least one of A, B, and C, etc.” is used, in generalsuch a construction is intended in the sense one having skill in the artwould understand the convention (e.g., “a system having at least one ofA, B, and C” would include but not be limited to systems that have Aalone, B alone, C alone, A and B together, A and C together, B and Ctogether, and/or A, B, and C together, etc.). In those instances where aconvention analogous to “at least one of A, B, or C, etc.” is used, ingeneral such a construction is intended in the sense one having skill inthe art would understand the convention (e.g., “a system having at leastone of A, B, or C” would include but not be limited to systems that haveA alone, B alone, C alone, A and B together, A and C together, B and Ctogether, and/or A, B, and C together, etc.). It will be furtherunderstood by those within the art that typically a disjunctive wordand/or phrase presenting two or more alternative terms, whether in thedescription, claims, or drawings, should be understood to contemplatethe possibilities of including one of the terms, either of the terms, orboth terms unless context dictates otherwise. For example, the phrase “Aor B” will be typically understood to include the possibilities of “A”or “B” or “A and B.”

With respect to the appended claims, those skilled in the art willappreciate that recited operations therein may generally be performed inany order. Also, although various operational flow diagrams arepresented in a sequence(s), it should be understood that the variousoperations may be performed in other orders than those which areillustrated, or may be performed concurrently. Examples of suchalternate orderings may include overlapping, interleaved, interrupted,reordered, incremental, preparatory, supplemental, simultaneous,reverse, or other variant orderings, unless context dictates otherwise.Furthermore, terms like “responsive to,” “related to,” or otherpast-tense adjectives are generally not intended to exclude suchvariants, unless context dictates otherwise.

It is worthy to note that any reference to “one aspect,” “an aspect,”“an exemplification,” “one exemplification,” and the like means that aparticular feature, structure, or characteristic described in connectionwith the aspect is included in at least one aspect. Thus, appearances ofthe phrases “in one aspect,” “in an aspect,” “in an exemplification,”and “in one exemplification” in various places throughout thespecification are not necessarily all referring to the same aspect.Furthermore, the particular features, structures or characteristics maybe combined in any suitable manner in one or more aspects.

Any patent application, patent, non-patent publication, or otherdisclosure material referred to in this specification and/or listed inany Application Data Sheet is incorporated by reference herein, to theextent that the incorporated materials is not inconsistent herewith. Assuch, and to the extent necessary, the disclosure as explicitly setforth herein supersedes any conflicting material incorporated herein byreference. Any material, or portion thereof, that is said to beincorporated by reference herein, but which conflicts with existingdefinitions, statements, or other disclosure material set forth hereinwill only be incorporated to the extent that no conflict arises betweenthat incorporated material and the existing disclosure material.

In summary, numerous benefits have been described which result fromemploying the concepts described herein. The foregoing description ofthe one or more forms has been presented for purposes of illustrationand description. It is not intended to be exhaustive or limiting to theprecise form disclosed. Modifications or variations are possible inlight of the above teachings. The one or more forms were chosen anddescribed in order to illustrate principles and practical application tothereby enable one of ordinary skill in the art to utilize the variousforms and with various modifications as are suited to the particular usecontemplated. It is intended that the claims submitted herewith definethe overall scope.

Various aspects of the subject matter described herein under the heading“ADJUSTMENT OF COMPRESSION FORCE APPLIED TO TISSUE BASED ON PROPORTIONOF ENERGY MODALITIES” are set out in the following examples:

Example 1

A method of adjusting a compression force applied by a surgicalinstrument, wherein the surgical instrument comprises an end effectorand a clamp arm configured to receive energy modalities from a generatorconfigured to deliver a plurality of energy modalities to the surgicalinstrument. The method comprises determining, by a control circuit,tissue impedance of tissue in contact with an end effector of thesurgical instrument; determining, by the control circuit, a tissue typebased on the tissue impedance; selecting, by the control circuit, afirst energy modality of the plurality of energy modalities to deliverto the surgical instrument; generating, by the control circuit, a firstsignal waveform based on the first energy modality; selecting, by thecontrol circuit, a second energy modality of the plurality of energymodalities to deliver to the surgical instrument; generating, by thecontrol circuit, a second signal waveform based on the second energymodality; outputting, by the generator, the first and second signalwaveform to deliver energy to the end effector; and adjusting, by thecontrol circuit, a compression force applied by the end effector bychanging a size of a gap between the tissue and the clamp arm based on aproportion of the first signal waveform to the second signal waveform.

Example 2

The method of Example 1, wherein the first energy modality is a radiofrequency (RF) energy modality and the second energy modality is anultrasonic energy modality.

Example 3

The method of Example 1 or 2, wherein determining the tissue impedancecomprises: applying, by the generator, a non-therapeutic electricalsignal to the end effector over a range of frequencies; and determining,by the control circuit, an impedance characteristic pattern based onspectral analysis of the non-therapeutic electrical signal.

Example 4

The method of any one of Examples 1-3, wherein the proportion isdetermined by the control circuit based on a time that each of the firstand second signal waveform is applied during a surgical treatment cycleor amplitude of each of the first and second signal waveform or acombination thereof.

Example 5

The method of any one of Examples 1-4, wherein adjusting the compressionforce comprises actuating a mechanical switch coupled to the clamp arm,wherein a first position of the mechanical switch corresponds to a firstactuation of the clamp arm resulting in high compression force, andwherein a second position of the mechanical switch corresponds to asecond actuation of the clamp arm resulting in low compression force.

Example 6

The method of any one of Examples 1-5, wherein adjusting the compressionforce comprises expanding an electroactive polymer coupled to the clamparm, and wherein expanding the electroactive polymer based on applyingthe first and second signal waveform to the end effector.

Example 7

A surgical instrument comprises a control circuit. The control circuitis configured to communicatively couple to a generator configured todeliver a plurality of energy modalities to an end effector of thesurgical instrument, wherein the control circuit is further configuredto: determine tissue impedance of tissue in contact with an end effectorof the surgical instrument; determine a tissue type of based on thetissue impedance; select a first energy modality of the plurality ofenergy modalities; generate a first signal waveform based on the firstenergy modality; select a second energy modality of the plurality ofenergy modalities; generate a second signal waveform based on the secondenergy modality; and adjust a compression force applied by an endeffector to tissue by changing a gap between tissue and an end effectorbased on a proportion of the first signal waveform to the second signalwaveform.

Example 8

The surgical instrument of Example 7, further comprising an end effectorcoupled to the control circuit, wherein the end effector comprises aclamp arm and an ultrasonic blade.

Example 9

The surgical instrument of Example 7 or 8, further comprising agenerator coupled to the control circuit.

Example 10

The surgical instrument of any one of Examples 7-10, wherein the controlcircuit determines proportion based on a time that each of the first andsecond signal waveform are applied during a surgical treatment cycle oramplitude of each of the first and second signal waveform or acombination thereof.

Example 11

The surgical instrument of any one of Examples 7-10, wherein the controlcircuit adjusts the compression force based on actuating a mechanicalswitch coupled to the clamp arm, wherein a first position of themechanical switch corresponds to a first actuation of the clamp armresulting in high compression force, and wherein a second position ofthe mechanical switch corresponds to a second actuation of the clamp armresulting in low compression force.

Example 12

The surgical instrument of any one of Examples 7-11, wherein the controlcircuit adjusts the compression force based on expansion of anelectroactive polymer coupled to the clamp arm, and wherein theelectroactive polymer expands based on applying the first and secondsignal waveform to the end effector.

Example 13

A surgical system comprises a surgical hub configured to receive atissue treatment algorithm transmitted from a cloud computing system,wherein the surgical hub is communicatively coupled to the cloudcomputing system; and a surgical instrument communicatively coupled tothe surgical hub, wherein the surgical instrument comprises: an endeffector comprising: a clamp arm; and a ultrasonic blade; a generatorconfigured to deliver a plurality of energy modalities to the endeffector; a control circuit communicatively coupled to the end effectorand the generator, wherein the control circuit is configured to treattissue, and wherein the control circuit is configured to: determinetissue impedance of tissue in contact with the end effector; determinetissue type based on the tissue impedance; select a first energymodality of the plurality of energy modalities; generate a first signalwaveform based on the first energy modality; select a second energymodality of the plurality of energy modalities; generate a second signalwaveform based on the second energy modality; apply the first and secondsignal waveform to the end effector; and adjust a compression forceapplied by the end effector by changing a size of a gap between thetissue and the waveguide based on a proportion of the first signalwaveform to the second signal waveform.

Example 14

The surgical instrument of Example 13, wherein the first energy modalityis a radio frequency (RF) energy modality and the second energy modalityis an ultrasonic energy modality.

Example 15

The surgical instrument of Example 13 or 14, wherein to determine thetissue impedance, the control circuit is configured: apply anon-therapeutic electrical signal to the end effector over a range offrequencies; and determine an impedance characteristic pattern based onspectral analysis of the non-therapeutic electrical signal.

Example 16

The surgical instrument of any one of Examples 13-15, wherein thecontrol circuit determines the proportion based on a time that each ofthe first and second signal waveform are applied during a surgicaltreatment cycle or an amplitude of each of the first and second signalwaveform or a combination thereof.

Example 17

The surgical instrument of any one of Examples 13-16, wherein to adjustthe compression force, the control circuit is configured to actuate amechanical switch coupled to the clamp arm, wherein a first position ofthe mechanical switch corresponds to a first actuation of the clamp armresulting in high compression force, and wherein a second position ofthe mechanical switch corresponds to a second actuation of the clamp armresulting in low compression force.

Example 18

The surgical instrument of any one of Examples 13-17, wherein to adjustthe compression force, the control circuit is configured to expand anelectroactive polymer coupled to the clamp arm, and to expand theelectroactive polymer based on the first and second signal waveformsapplied to the end effector.

Example 19

The surgical instrument of any one of Examples 14-18, wherein the RFenergy modality corresponds to a first range of compression force andthe ultrasonic energy modality to a second range of compression force,and wherein the first range of compression force is greater than thesecond range of compression force.

Example 20

The surgical instrument of any one of Examples 13-19, wherein thesurgical instrument comprises a passive electrode and an activeelectrode.

The invention claimed is:
 1. A method of adjusting a compression forceapplied by a surgical instrument, wherein the surgical instrumentcomprises an end effector and a clamp arm configured to receive energymodalities from a generator configured to deliver a plurality of energymodalities to the surgical instrument, the method comprising:determining, by a control circuit, tissue impedance of tissue in contactwith the end effector of the surgical instrument; determining, by thecontrol circuit, a tissue type based on the tissue impedance; selecting,by the control circuit, a first energy modality of the plurality ofenergy modalities to deliver to the surgical instrument; generating, bythe control circuit, a first signal waveform based on the first energymodality; selecting, by the control circuit, a second energy modality ofthe plurality of energy modalities to deliver to the surgicalinstrument; generating, by the control circuit, a second signal waveformbased on the second energy modality; outputting, by the generator, thefirst and second signal waveform to deliver energy to the end effector;and adjusting, by the control circuit, a compression force applied bythe end effector by changing a size of a gap between the tissue and theclamp arm based on a proportion of the first signal waveform to thesecond signal waveform.
 2. The method of claim 1, wherein the firstenergy modality is a radio frequency (RF) energy modality and the secondenergy modality is an ultrasonic energy modality.
 3. The method of claim1, wherein determining the tissue impedance comprises: applying, by thegenerator, a non-therapeutic electrical signal to the end effector overa range of frequencies; and determining, by the control circuit, animpedance characteristic pattern based on spectral analysis of thenon-therapeutic electrical signal.
 4. The method of claim 1, wherein theproportion is determined by the control circuit based on a time thateach of the first and second signal waveforms is applied during asurgical treatment cycle or amplitude of each of the first and secondsignal waveforms or a combination thereof.
 5. The method of claim 1,wherein adjusting the compression force comprises actuating a mechanicalswitch coupled to the clamp arm, wherein a first position of themechanical switch corresponds to a first actuation of the clamp armresulting in high compression force, and wherein a second position ofthe mechanical switch corresponds to a second actuation of the clamp armresulting in low compression force.
 6. The method of claim 1, whereinadjusting the compression force comprises expanding an electroactivepolymer coupled to the clamp arm, and wherein expanding theelectroactive polymer is based on applying the first and second signalwaveform to the end effector.
 7. A surgical instrument comprising: acontrol circuit configured to communicatively couple to a generatorconfigured to deliver a plurality of energy modalities to an endeffector of the surgical instrument, wherein the control circuit isfurther configured to: determine tissue impedance of tissue in contactwith the end effector of the surgical instrument; determine a tissuetype of based on the tissue impedance; select a first energy modality ofthe plurality of energy modalities; generate a first signal waveformbased on the first energy modality; select a second energy modality ofthe plurality of energy modalities; generate a second signal waveformbased on the second energy modality; and adjust a compression forceapplied by the end effector to tissue by changing a gap between thetissue and the end effector based on a proportion of the first signalwaveform to the second signal waveform.
 8. The surgical instrument ofclaim 7, further comprising the end effector coupled to the controlcircuit, wherein the end effector comprises a clamp arm and anultrasonic blade.
 9. The surgical instrument of claim 8, furthercomprising the generator coupled to the control circuit.
 10. Thesurgical instrument of claim 7, wherein the control circuit determinesthe proportion based on a time that each of the first and second signalwaveforms is applied during a surgical treatment cycle or amplitude ofeach of the first and second signal waveforms or a combination thereof.11. The surgical instrument of claim 7, wherein the control circuitadjusts the compression force based on actuating a mechanical switchcoupled to a clamp arm of the end effector, wherein a first position ofthe mechanical switch corresponds to a first actuation of the clamp armresulting in high compression force, and wherein a second position ofthe mechanical switch corresponds to a second actuation of the clamp armresulting in low compression force.
 12. The surgical instrument of claim7, wherein the control circuit adjusts the compression force based onexpansion of an electroactive polymer coupled to a clamp arm of the endeffector, and wherein the electroactive polymer expands based onapplying the first and second signal waveform to the end effector.
 13. Asurgical system comprising: a surgical hub configured to receive atissue treatment algorithm transmitted from a cloud computing system,wherein the surgical hub is communicatively coupled to the cloudcomputing system; and a surgical instrument communicatively coupled tothe surgical hub, wherein the surgical instrument comprises: an endeffector comprising: a clamp arm; and a ultrasonic blade; a generatorconfigured to deliver a plurality of energy modalities to the endeffector; a control circuit communicatively coupled to the end effectorand the generator, wherein the control circuit is configured to treattissue, and wherein the control circuit is configured to: determinetissue impedance of tissue in contact with the end effector; determinetissue type based on the tissue impedance; select a first energymodality of the plurality of energy modalities; generate a first signalwaveform based on the first energy modality; select a second energymodality of the plurality of energy modalities; generate a second signalwaveform based on the second energy modality; apply the first and secondsignal waveform to the end effector; and adjust a compression forceapplied by the end effector by changing a size of a gap between thetissue and the ultrasonic blade based on a proportion of the firstsignal waveform to the second signal waveform.
 14. The surgical systemof claim 13, wherein the first energy modality is a radio frequency (RF)energy modality and the second energy modality is an ultrasonic energymodality.
 15. The surgical system of claim 13, wherein to determine thetissue impedance, the control circuit is configured: apply anon-therapeutic electrical signal to the end effector over a range offrequencies; and determine an impedance characteristic pattern based onspectral analysis of the non-therapeutic electrical signal.
 16. Thesurgical system of claim 13, wherein the control circuit determines theproportion based on a time that each of the first and second signalwaveforms is applied during a surgical treatment cycle or an amplitudeof each of the first and second signal waveforms or a combinationthereof.
 17. The surgical system of claim 13, wherein to adjust thecompression force, the control circuit is configured to actuate amechanical switch coupled to the clamp arm, wherein a first position ofthe mechanical switch corresponds to a first actuation of the clamp armresulting in high compression force, and wherein a second position ofthe mechanical switch corresponds to a second actuation of the clamp armresulting in low compression force.
 18. The surgical system of claim 13,wherein to adjust the compression force, the control circuit isconfigured to expand an electroactive polymer coupled to the clamp arm,and wherein expanding the electroactive polymer is based on the firstand second signal waveforms being applied to the end effector.
 19. Thesurgical system of claim 14, wherein the RF energy modality correspondsto a first range of compression force and the ultrasonic energy modalityto a second range of compression force, and wherein the first range ofcompression force is greater than the second range of compression force.20. The surgical system of claim 13, wherein the surgical instrumentcomprises a passive electrode and an active electrode.